Sodium Bicarbonate Group Research Articles

13-Week Repeated Oral Toxicity and Toxicokinetic Studies of Rabeprazole Sodium and Sodium Bicarbonate Combination in Dogs.

The subchronic toxicity and toxicokinetics of a combination of rabeprazole sodium and sodium bicarbonate were investigated in dogs by daily oral administration for 13 consecutive weeks with a 4-week recovery period. The dose groups consisted of control (vehicles), (5 + 200), (10 + 400), and (20 + 800) mg/kg of rabeprazole sodium + sodium bicarbonate, 20mg/kg of rabeprazole sodium only, and 800mg/kg of sodium bicarbonate only. Esophageal ulceration accompanied by inflammation was observed in only one animal in the male (20 + 800) mg/kg rabeprazole sodium + sodium bicarbonate group. However, the severity of the ulceration was moderate, and the site of occurrence was focally extensive; thus, it was assumed to be a treatment-related effect of rabeprazole sodium + sodium bicarbonate. In the toxicokinetics component of this study, systemic exposure to rabeprazole sodium (AUClast and Cmax at Day 91) was greater in males than females, suggesting sex differences. AUClast and Cmax at Day 91 were increased compared to those on Day 1 in a dose-dependent manner. A delayed Tmax and no drug accumulation were observed after repeated dosage. In conclusion, we suggest under the conditions of this study that the no-observed-adverse-effect level (NOAEL) of the combination of rabeprazole sodium + sodium bicarbonate in male and female dogs is (10 + 400) and (20 + 800) mg/kg, respectively.

#356 Low-dose thiazide/fludrocortisone use in advanced CKD can rapidly improve potassium-elevated metabolic acidosis with renal and cardiovascular safety

Abstract Background and Aims Advanced chronic kidney disease (CKD) is often complicated by metabolic acidosis(MA) with elevated serum potassium(K). MA is a risk factor for CKD progression, and elevated serum K forces dietary K restriction, which is also undesirable in CKD, stalling the use and escalation of renin-angiotensin-aldosterone system inhibitors (RAASi). Sodium bicarbonate(SB) and K binders, which are not well tolerated due to gastrointestinal symptoms, are often used to correct MA and hyperkalemia. On the other hand, the concurrent use of thiazide and fludrocortisone to promote urinary excretion of K and hydrogen ions has been reported in the type IV renal tubular acidosis, but its efficacy and safety in advanced CKD is unclear. Method This single-center, retrospective, observational study included CKDG3b-G5 outpatients with MA([HCO3−]<22 mM) and elevated K (serum [K]≥ 5.0 mEq/L) at our center. A total of 59 patients were selected, excluding those who had already been prepared for renal replacement therapy at the start of treatment. Patients who continued to receive trichlormethiazide (1 mg, at 1-3 day intervals) plus fludrocortisone (0.1 mg, at 1-3 day intervals) (low-T/F group, N = 10) or SB(0.5 g-5 g/day) alone (SB group, N = 49) were followed up until 2 years after the start of treatment and the two groups were compared. Background factors including age, sex, cause of CKD, estimated glomerular filtration rate (eGFR), CKD stage, urinary protein(g/gCr),serum [K]/ [HCO3−]/[Na]/[CL]/albumin/phosphate, hemoglobin levels, and the use of RAASi/K binders/diuretics were investigated. Efficacy and safety comparisons between the two groups were evaluated based on changes in serum [HCO3−]and [K] levels before and after starting of treatment (at 2, 6, 12, 18, and 24 months), percentage of patients achieving [HCO3−] ≥22 mM, change in eGFR, incidence of renal events (>30% reduction in eGFR or renal replacement therapy), the incidence of cardiovascular events, and the incidence of treatment-modified events such as initiation or increase of antihypertensive, K-binding, and uric acid-lowering agents. Results In all 59 subjects, the mean age was 72.0±11.7 years, 81% were male, mean eGFR was 19.6 ± 7.2 mL/min/1.73 m2, CKDG4/5 account for 92% (G4 60%/G5 32%), primary disease was diabetic nephropathy 30%, nephrosclerosis 43%, RAASi use 68%, mean [K] was 5.5 ± 0.4 mEq/L and mean [HCO3−] was 18.1 ± 2.2 mM. The low-T/F group consisted of patients who switched due to prior SB intolerance or in whom SB was ineffective, and included 5 patients who received concomitant SB. Comparison of background factors showed no significant difference between the two groups. The changes in the serum [HCO3−] and [K] levels 2 months after starting the treatment were significantly larger in the low-T/F group compared with the SB group ([K]after - [K]before (mEq/L):median −1.2, IQR-1.6 to −0.48 vs −0.57, −0.80 to −0.10, p = 0.036; {[K]after -[K]before}×100/[K]before(%): median −20.3, IQR −26.4 to −9.2 vs −9.3, −14.8 to −1.85, p = 0.032; [HCO3−]after-[HCO3−]before (mM):median +5.2, IQR +3.75 to +8.23 vs +3.2, +1.7 to +5.1, p = 0.022) . The percentage of patients achieving [HCO3−] ≥22 mM at 2 months after treatment was significantly higher in the low-T/F group at 88.9% (SB group 38.8%, p = 0.007). There were no renal events in the low-T/F group, and cumulative renal survival (no renal events) tended to be higher in the low-T/F group than in the SB group in the all conditions such as unadjusted condition, presence of RAASi, CKDG4/5 and matched for age, sex, primary cause of CKD and eGFR (p = 0.06, p = 0.265, p = 0.16, p = 0.14, respectively) (Figure). In patients with no renal events, the low-T/F group had a significantly better mean eGFR change of +4.2% at 6 months (SB group: −11.0%, p = 0.019). There were also no cardiovascular events in the low-T/F group, and there were no significant differences between the two groups in either cardiovascular events or treatment-modified events (Table). Conclusion Even in advanced CKD, the low-dose combination of thiazide and fludrocortisone can rapidly improve K-elevating MA and continue without adverse renal or cardiovascular outcomes.

#67 Is Sodium bicarbonate a better alternative in kidney transplantation for better early renal function? A systematic review and meta-analysis

Abstract Background and Aims Kidney transplantation is a choice treatment for end-stage renal disease. It is the most cost-effective treatment and significantly improves the quality of life. However, metabolic acidosis increased following the transplantation. It can lead to several undesirable effects, such as disturbing the protein balance, resulting in a negative nitrogen equilibrium, increased protein degradation and essential amino acid oxidation, reduced physical functioning, and consequently decreased quality of life. The intraoperative crystalloid used may have significant effects on early function and acid-base balance. Also, sodium bicarbonate may enhance early graft function. This study aims to compare the effect of sodium bicarbonate in enhancing early graft function post-renal transplantation. Method We conducted a comprehensive search on multiple databases, including PubMed, MEDLINE, Embase, Scopus, WOS, and the Central Cochrane Registry. We included randomized controlled trials (RCTs) that compared sodium bicarbonate to normal saline during intraoperative kidney transplantation. Results Our search retrieved three RCTs, with 246 patients eligible for our criteria. We used either fixed- or random-effects models in the quantitative synthesis of the eligible studies accounting for clinical heterogeneity. Pooled data revealed that the sodium bicarbonate group was associated with a significantly improve in PH level (MD = 0.1; 95% CI: 0.06, 0.13; P < 0.01), Base Excess level (MD = 4.60 mEq/L; 95% CI: 3.43, 5.77; P = 0.003), and urine volume (MD = 2.59 L; 95% CI: 0.88, 4.29; P < 0.01). However, there was no significant difference between two groups in decreasing creatinine level after first day (MD = −0.46 mg/dl; 95% CI: −1.68, 0.76; P = 0.46), but the creatinine level significantly decreases after 2nd day (MD = −1.11 mg/dl; 95% CI: −1.96, −0.26; P = 0.01), and 3rd day (MD = −1 mg/dl; 95% CI: −1.17, −0.72; P < 0.01). Conclusion Our study suggests a potential advantage of sodium bicarbonate over the normal saline solution as an intraoperative fluid in improving metabolic acidosis during kidney transplantation.

Effects of a Modified Long-Acting Cocktail on Analgesia and Enhanced Recovery After Total Hip Arthroplasty: A Double-Blinded Randomized Clinical Trial

BackgroundWe compared the efficacy and safety of a modified cocktail for postoperative analgesia and early functional rehabilitation in patients undergoing total hip arthroplasty (THA). MethodsMagnesium sulfate and sodium bicarbonate were added to a cocktail of ropivacaine, epinephrine, and dexamethasone. Primary outcome measures were visual analog scale (VAS) pain scores at various intervals after surgery, morphine consumption for rescue analgesia after surgery, and time to first rescue analgesia. Secondary outcomes were hip function after surgery, daily walking distance, quadriceps muscle strength, and the incidence of postoperative adverse reactions. ResultsMorphine consumption was significantly lower in the modified cocktail group than in the control group in the first 24 hours after surgery (6.2 ± 6.0 versus 14.2 ± 6.4 mg, P < .001), as was total morphine consumption (10.0 ± 8.6 versus 19.2 ± 10.1 mg, P < .001). The duration of the first rescue analgesia was significantly prolonged (23.7 ± 10.3 versus 11.9 ± 5.8 mg, P < .001). Morphine consumption was also reduced in the magnesium sulfate and sodium bicarbonate groups over a 24-hour period compared to the control group (P < .001). The modified cocktail group had significantly lower resting VAS pain scores than the control group within 24 hours after surgery (P < .050). The VAS pain scores during movement within 12 hours after surgery were also lower (P < .050). The experimental groups showed better hip range of motion (P < .050) and longer walking distance (P < .050) on the first postoperative day, and levels of inflammatory markers were significantly reduced. The incidence of postoperative adverse reactions was similar among the 4 groups. ConclusionsThe modified cocktail with a new adjuvant can prolong the duration of postoperative analgesia, reduce the dosage of rescue analgesics, and accelerate early postoperative functional recovery in patients undergoing THA.

Tumor alkalization therapy: misconception or good therapeutics perspective? - the case of malignant ascites.

Tumor acidity has been identified as a key factor in promoting cancer progression, metastasis, and resistance. Tumor alkalization therapy has emerged as a potential strategy for cancer treatment. This article provides preclinical and clinical evidence for tumor alkalization therapy as a promising cancer treatment strategy. The potential of tumor alkalization therapy using sodium bicarbonate in the treatment of malignant ascites was studied. The concept of intraperitoneal perfusion with an alkalizing solution to increase the extracellular pH and its antitumor effect were explored. The significant extension in the overall survival of the Ehrlich ascites carcinoma mice treated with sodium bicarbonate solution compared to those treated with a sodium chloride solution was observed. In the sodium bicarbonate group, mice had a median survival of 30 days after tumor cell injection, which was significantly (p<0.05) different from the median survival of 18 days in the sodium chloride group and 14 days in the intact group. We also performed a case study of a patient with ovarian cancer malignant ascites resistant to previous lines of chemotherapy who underwent intraperitoneal perfusions with a sodium bicarbonate solution, resulting in a significant drop of CA-125 levels from 5600 U/mL to 2200 U/mL in and disappearance of ascites, indicating the potential effectiveness of the treatment. The preclinical and clinical results obtained using sodium bicarbonate perfusion in the treatment of malignant ascites represent a small yet significant contribution to the evolving field of tumor alkalization as a cancer therapy. They unequivocally affirm the good prospects of this concept.

A novel air-polishing powder from natural eggshell.

This study compares the ability of extrinsic stain removal and surface roughness changes on tooth surfaces after using two different types of dental air polishing powder: Sodium bicarbonate and novel eggshell powder. For the study of extrinsic stain removal, twenty bovine teeth were soaked in coffee for extrinsic stain formation. Group 1 and Group 2 were polished with sodium bicarbonate powder and novel eggshell powder, respectively. The acquired stains of teeth were recorded as baseline, and color changes after cleaning with two different powders were also measured by colorimeter. Sixteen samples from eight human posterior teeth were used for the surface roughness test. Surface roughness values (Sa) of two groups (sodium bicarbonate and novel eggshell powder) were measured by a contact-type profilometer before and after polishing with two types of powders. The data showed that the average ΔE* value of the sodium bicarbonate group was higher than that of the novel eggshell powder group (P < 0.05). The average ΔSa value of the sodium bicarbonate group was higher than that of the novel eggshell powder group (P < 0.05). Sodium bicarbonate powder showed higher stain removal ability and surface roughness changes than the novel eggshell powder.

COMPARATIVE EFFICACY OF CHLORHEXIDINE AND SODIUM BICARBONATE DENTIFRICES IN PLAQUE AND GINGIVAL INFLAMMATION REDUCTION: A RANDOMIZED CONTROLLED TRIAL

Objectives: To determine the effi cacy of Chlorhexidine dentifrice compared to Sodium Bicarbonate dentifrice in plaque and gingival Infl ammation reduction. Materials and Methods: From May 2022 to August 2022, a randomized controlled experiment was carried out in the Periodontology Department of Sardar Begum Dental College and Hospital Peshawar. Using WHO formulae for sample size, 98 patients were selected. The age range of the patient was chosen between 13-40 years. The mean age presentation was 19.7 ± 4.9 years. The females were N=56 (57.1%) predominant than males N=42 (42.9%). The patients were placed into two groups of 49 each. Group A received dentifrice containing chlorhexidine, whereas Group B received dentifrice containing sodium bicarbonate. The data was entered into a structured proforma. SPSS 22.0 was used to analyze data. The Chi-Square test was used to compare the means of the two groups. Values of ≤ .05 were considered signifi cant. Results: The mean plaque scores for both groups are shown in Table 7. Group A (Chlorhexidine group) participants had an initial mean plaque score of 2.7, while the plaque score after the intervention was 1.2. The initial mean plaque score was 2.7 in the participants of group B (Sodium Bicarbonate group), while the mean plaque score after intervention was 1.75. This shows that both dentifrices reduced plaque but chlorhexidine was more eff ective than sodium bicarbonate in plaque reduction. Similarly, both (Chlorhexidine and Sodium Bicarbonate) reduced the gingival index score, but chlorhexidine was more eff ective than sodium bicarbonate in reducing gingival inflammation. Conclusion: Both the dentifrices show a significant reduction in both the plaque scores and gingival scores after usage. Chlorhexidine group showed a notable reduction in plaque and gingival scores as compared to sodium bicarbonate.

Efficacy and safety of tart cherry supplementary citrate mixture on gout patients: a prospective, randomized, controlled study

BackgroundLow urine pH, which may be mediated by metabolic syndrome (MetS), is common in gout. Tart cherries are shown to improve MetS symptoms and possess anti-inflammatory properties. However, the efficacy of tart cherry supplements on urine pH has yet to be studied.ObjectivesThis study aimed to investigate the efficacy and safety of tart cherry supplementary citrate (TaCCi) mixture on urine pH, serum urate (sUA), C-reactive protein (CRP), and gout flares in gout patients initiating urate-lowering therapy (ULT), in comparison to citrate mixture and sodium bicarbonate.MethodsA prospective, randomized (1:1:1), open-label, parallel-controlled trial was conducted among 282 men with gout and fasting urine pH ≤ 6, who were initiating ULT with febuxostat (initially 20 mg daily, escalating to 40 mg daily if serum urate ≥ 360 μmol/L). Participants were randomized to groups taking either sodium bicarbonate, citrate mixture, or TaCCi mixture. All participants were followed every 4 weeks until week 12. Urine pH and sUA were co-primary outcomes, with various biochemical and clinical secondary endpoints.ResultsUrine pH increased to a similar extent in all three groups. SUA levels declined in all three groups as well, with no significant differences observed between the groups. At week 12, the TaCCi mixture group exhibited a greater reduction in the urine albumin/creatinine ratio (UACR) compared to the other two groups (p < 0.05). Participants taking TaCCi mixture or citrate mixture experienced fewer gout flares than those in the sodium bicarbonate group over the study period (p < 0.05). Additionally, the TaCCi mixture group had a lower CRP level at week 12 relative to the other two groups (p < 0.01). Adverse events were similar across all three groups.ConclusionThe TaCCi mixture had similar efficacy and safety on urine alkalization and sUA-lowering as the citrate mixture and sodium bicarbonate in patients with gout. However, the TaCCi mixture resulted in greater improvements in UACR and CRP, which suggests that tart cherry supplements may provide additional benefits for renal protection and reduce inflammation in gout, particularly when starting ULT.Trial registrationThis project was registered in ChiCTR (www.chictr.org.cn), with the registration number: ChiCTR2100050749.

Sodium Bicarbonate for Metabolic Acidosis in the ICU: Results of a Pilot Randomized Double-Blind Clinical Trial.

To identify the best population, design of the intervention, and to assess between-group biochemical separation, in preparation for a future phase III trial. Investigator-initiated, parallel-group, pilot randomized double-blind trial. Eight ICUs in Australia, New Zealand, and Japan, with participants recruited from April 2021 to August 2022. Thirty patients greater than or equal to 18 years, within 48 hours of admission to the ICU, receiving a vasopressor, and with metabolic acidosis (pH < 7.30, base excess [BE] < -4 mEq/L, and Paco2 < 45 mm Hg). Sodium bicarbonate or placebo (5% dextrose). The primary feasibility aim was to assess eligibility, recruitment rate, protocol compliance, and acid-base group separation. The primary clinical outcome was the number of hours alive and free of vasopressors on day 7. The recruitment rate and the enrollment-to-screening ratio were 1.9 patients per month and 0.13 patients, respectively. Time until BE correction (median difference, -45.86 [95% CI, -63.11 to -28.61] hr; p < 0.001) and pH correction (median difference, -10.69 [95% CI, -19.16 to -2.22] hr; p = 0.020) were shorter in the sodium bicarbonate group, and mean bicarbonate levels in the first 24 hours were higher (median difference, 6.50 [95% CI, 4.18 to 8.82] mmol/L; p < 0.001). Seven days after randomization, patients in the sodium bicarbonate and placebo group had a median of 132.2 (85.6-139.1) and 97.1 (69.3-132.4) hours alive and free of vasopressor, respectively (median difference, 35.07 [95% CI, -9.14 to 79.28]; p = 0.131). Recurrence of metabolic acidosis in the first 7 days of follow-up was lower in the sodium bicarbonate group (3 [20.0%] vs. 15 [100.0%]; p < 0.001). No adverse events were reported. The findings confirm the feasibility of a larger phase III sodium bicarbonate trial; eligibility criteria may require modification to facilitate recruitment.

Decompensated metabolic acidosis in the emergency department: Epidemiology, sodium bicarbonate therapy, and clinical outcomes

ObjectiveThis article aims to describe the epidemiology of decompensated metabolic acidosis, the characteristics of sodium bicarbonate (SB) administration and outcomes in emergency department (ED) patients. DesignThis is a retrospective cohort study. SettingED of a tertiary referral hospital in Melbourne, Australia. ParticipantsAdult patients presenting to the ED between 1 July 2011 and 20 September 2020 with decompensated metabolic acidosis diagnosed on arterial blood gas (ABG). Main outcome measuresWe compared characteristics between those treated with or without SB. We studied SB administration characteristics, change in laboratory variables, factors associated with use and dose, and clinical outcomes. ResultsAmong 753,613 ED patients, 314 had decompensated metabolic acidosis on ABG, with 17.8% receiving SB. Patients in the SB group had lower median pH, CO2, bicarbonate, and base excess (BE) levels compared with the No SB group (P < 0.01). The median number of SB doses in the SB group was one treatment. This was given at a median total dose of 100 mmol and at a median of 2.8 h after the diagnostic blood gas results. Only 42% of patients in the SB group had a subsequent blood gas measured. In such patients, there was no significant change in pH, bicarbonate, or BE. SB therapy was not independently associated with mortality. ConclusionsABG-confirmed decompensated metabolic acidosis was rare but associated with a high mortality. SB administration occurred in a minority of patients and in more acidaemic patients. However, SB dose was stereotypical and not tailored to acidosis severity. Assessment of SB effect was infrequent and showed no correction of acidosis. Systematic studies of titrated SB therapy are required to inform current practice.

Early sodium bicarbonate therapy for critically ill patients with septic shock and acute moderate metabolic acidosis

To the editor: In recent decades, septic shock has continued to be a life-threatening health problem around the world.[1] Meanwhile, metabolic acidosis (MA) is also well known in critically ill patients, and even moderate metabolic acidosis (MMA) is associated with higher mortality than sepsis.[2] Although the administration of sodium bicarbonate (SB) is widely used in sepsis shock with MA in the intensive care unit (ICU), its clinical efficacy is not well established. In the 2021 update of the Surviving Sepsis Campaign guidelines, Evans et al. recommend the administration of SB in adults with septic shock, severe metabolic acidemia (pH ≤7.2), and acute kidney injury (AKI, AKIN score 2 or 3).[3,4] However, clinical evidence for the efficacy of the administration of SB in critically ill patients with septic shock and acute MMA is still limited. We retrospectively investigated a large ICU database (MIMIC-IV, https://www.physionet.org/) from 2008 to 2019 in 6 ICUs at a single-center hospital (Beth Israel Deaconess Medical Centre; Boston, MA). All adults with septic shock and acute MMA (7.2 < pH < 7.3, bicarbonate concentration <20 mmol/L, and PaCO2 <50 mmHg) within the first 48 hours after ICU admission were included in this study. Propensity score analysis[5] (PSA) was performed to account for differences in the probability of receiving or not receiving SB. For the PSA, we matched patients 1 to 1. The marginal structural Cox model[5] (MSCM) was developed to adjust for both baseline and time-varying confounding variables. The primary outcome was ICU and in-hospital mortality. Variables, including sex, age, body mass index, comorbidities on ICU admission, mechanical ventilation, vasopressors, and renal replacement therapy, were extracted from the MIMIC-IV database for the first 24 hours of ICU admission. Serum creatinine within the first 48 hours of an ICU stay was used to identify AKI stages. Administration of lactate solution for the first 24 hours was also included in the study. To account for the possible influence of clinical practice in previous years, the year of admission was used as a random factor in a mixed-effects model. Laboratory variables (PaO2, PaCO2, pH, and bicarbonate concentration) were recorded throughout the ICU period. For patients who underwent multiple tests, the highest values of lactate and PaCO2 and the lowest values of PaO2, bicarbonate concentration, and pH on each day were used for analysis. The above variables included in the PSA and MSCM are listed in Supplemental Table 1 (https://links.lww.com/ECCM/A58). A total of 577 patients with septic shock and MMA were identified, of whom 194 were included in the SB and 383 in the non-SB groups (Supplemental Table 2, https://links.lww.com/ECCM/A58). In the PSA group, early SB infusion was associated with both lower ICU mortality (hazards ratio [HR]: 0.61; 95% confidence interval [CI]: 0.40–0.93; P < 0.05) and lower in-hospital mortality (HR: 0.69; 95% CI: 0.50–0.97; P < 0.05; Fig. 1). In MSCM, our study also found a statistically significant positive effect of early SB infusion on ICU mortality (HR: 0.31; 95% CI: 0.13–0.72; P < 0.01) and hospital mortality (HR: 0.55; 95% CI: 0.31–0.97; P < 0.05) in patients with septic shock and MMA (Supplementary Figure 1, https://links.lww.com/ECCM/A59).Figure 1: Forest plot showing the effect of early sodium bicarbonate infusion on ICU and hospital mortality in the PSA for critically ill patients with septic shock and acute moderate metabolic acidosis. The hazard ratios were estimated using the PSA. After propensity score matching, 194 patients from the non-SB group were matched to SB group (n = 194) to balance the baseline differences in the probability to receive SB or not. The x-axis tick marks follow a logarithmic scale. ICU, intensive care unit; PSA, propensity score analysis; SB, sodium bicarbonate.Our observational study suggests that early infusion of SB in critically ill adult patients with septic shock and MMA within the first 48 hours after ICU admission has a significant beneficial effect on both ICU and hospital mortality. Further large, randomized, controlled clinical trials are needed to provide high-quality evidence to improve the Surviving Sepsis Campaign guidelines.

A Randomized Controlled Trial to Assess the Effects of Oral Alkali Therapy in Patients with Diabetic Kidney Disease

Background: To analyze the effects of oral alkali therapy on renal function, nutritional status and bone density in patients of diabetic kidney disease. Material &amp; Methods: A randomized controlled trial was conducted on 60 patients of age&gt;18 years with diabetic kidney disease who were not on dialysis and had plasma bicarbonate levels between 16 and 20 mmol/l. Patients were randomly divided into two groups: Test group (n=30) which received oral alkali therapy as sodium bicarbonate and control group (n=30) who did not receive oral alkali therapy. The patients were followed for 12 months to compare the improvement. Results: In comparison to controls, test group showed a significant improvement in the Hb (0.7 vs. 0.25, P =0.003), significantly less decrease in eGFR (-2.25 vs. -2.9, P=0.049), non-significant less increase in creatinine (-0.26 ± 0.4 vs. -0.43 ± 0.33, P=0.09), significant improvement in bicarbonate levels (7.5 vs. 1, p&lt;0.0001), significant restoration of albumin (0.32 vs. 0.05, P&lt;.0001), significant fall in iPTH levels (50 vs. 25, p=0.007) and ALP levels (32 vs. 12, p=0.015). Bone density (0.28 ± 0.17 vs. 0.01 ± 0.13, P&lt;.0001) and clinical well-being VAS scores improved significantly among the cases (9.83 ± 5.65 vs. -1.67 ± 7.11, P&lt;.0001). Conclusion: In conclusion, oral alkali therapy slows the rate of decline of renal function and the development of end stage renal disease in patients with advanced stages of CKD. This cheap and simple strategy, which is in line with current renal consensus documents, also improves the nutritional status of patients and bone density.

Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial

Metabolic acidosis is common in kidney transplant recipients and is associated with declining graft function. Sodium bicarbonate treatment effectively corrects metabolic acidosis, but no prospective studies have examined its effect on graft function. Therefore, we aimed to test whether sodium bicarbonate treatment would preserve graft function and slow the progression of estimated glomerular filtration rate (GFR) decline in kidney transplant recipients. The Preserve-Transplant Study was a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial at three University Hospitals in Switzerland (Zurich, Bern, and Geneva), which recruited adult (aged ≥18 years) male and female long-term kidney transplant recipients if they had undergone transplantation more than 1 year ago. Key inclusion criteria were an estimated GFR between 15 mL/min per 1·73 m2 and 89 mL/min per 1·73 m2, stable allograft function in the last 6 months before study inclusion (<15% change in serum creatinine), and a serum bicarbonate of 22 mmol/L or less. We randomly assigned patients (1:1) to either oral sodium bicarbonate 1·5-4·5 g per day or matching placebo using web-based data management software. Randomisation was stratified by study centre and gender using a permuted block design to guarantee balanced allocation. We did multi-block randomisation with variable block sizes of two and four. Treatment duration was 2 years. Acid-resistant soft gelatine capsules of 500 mg sodium bicarbonate or matching 500 mg placebo capsules were given at an initial dose of 500 mg (if bodyweight was <70 kg) or 1000 mg (if bodyweight was ≥70 kg) three times daily. The primary endpoint was the estimated GFR slope over the 24-month treatment phase. The primary efficacy analyses were applied to a modified intention-to-treat population that comprised all randomly assigned participants who had a baseline visit. The safety population comprised all participants who received at least one dose of study drug. The trial is registered with ClinicalTrials.gov, NCT03102996. Between June 12, 2017, and July 10, 2019, 1114 kidney transplant recipients with metabolic acidosis were assessed for trial eligibility. 872 patients were excluded and 242 were randomly assigned to the study groups (122 [50%] to the placebo group and 120 [50%] to the sodium bicarbonate group). After secondary exclusion of two patients, 240 patients were included in the intention-to-treat analysis. The calculated yearly estimated GFR slopes over the 2-year treatment period were a median -0·722 mL/min per 1·73 m2 (IQR -4·081 to 1·440) and mean -1·862 mL/min per 1·73 m2 (SD 6·344) per year in the placebo group versus median -1·413 mL/min per 1·73 m2 (IQR -4·503 to 1·139) and mean -1·830 mL/min per 1·73 m2 (SD 6·233) per year in the sodium bicarbonate group (Wilcoxon rank sum test p=0·51; Welch t-test p=0·97). The mean difference was 0·032 mL/min per 1·73 m2 per year (95% CI -1·644 to 1·707). There were no significant differences in estimated GFR slopes in a subgroup analysis and a sensitivity analysis confirmed the primary analysis. Although the estimated GFR slope did not show a significant difference between the treatment groups, treatment with sodium bicarbonate effectively corrected metabolic acidosis by increasing serum bicarbonate from 21·3 mmol/L (SD 2·6) to 23·0 mmol/L (2·7) and blood pH from 7·37 (SD 0·06) to 7·39 (0·04) over the 2-year treatment period. Adverse events and serious adverse events were similar in both groups. Three study participants died. In the placebo group, one (1%) patient died from acute respiratory distress syndrome due to SARS-CoV-2 and one (1%) from cardiac arrest after severe dehydration following diarrhoea with hypotension, acute kidney injury, and metabolic acidosis. In the sodium bicarbonate group, one (1%) patient had sudden cardiac death. In adult kidney transplant recipients, correction of metabolic acidosis by treatment with sodium bicarbonate over 2 years did not affect the decline in estimated GFR. Thus, treatment with sodium bicarbonate should not be generally recommended to preserve estimated GFR (a surrogate marker for graft function) in kidney transplant recipients with chronic kidney disease who have metabolic acidosis. Swiss National Science Foundation.

Clinical effectiveness of sodium bicarbonate therapy on mortality for septic patients with acute moderate lactic acidosis.

Objective: This study aimed to explore the effectiveness of sodium bicarbonate (SB) administration on mortality in septic patients with acute moderate lactic acidosis (MLA). Methods: The large ICU database (MIMIC-IV) was retrospectively analyzed. Patients with sepsis and acute MLA were identified. Propensity score analysis (PSA) was performed to explain baseline differences in the probability of accepting or not accepting SB. The edge structured cox model (MSCM) was used to adjust for baseline and time-varying confounding variables. The primary outcome was the ICU and hospital mortality. The subgroup of septic shock was also investigated. Results: A total of 512 septic patients with acute MLA were identified in this study, including 160 in the SB group and 352 in the non-SB group. In the PSA, SB administration was associated with reduced ICU (HR .58, 95% CI 0.38-.89; p <.05) and hospital (HR .67, 95% CI 0.47-.95; p <.05) mortality in septic patients with acute MLA. In the subgroup, the results were similar with septic patients. In the MSCM, SB administration could also improve the ICU (HR .35, 95% CI 0.16-.75; p <.01) and (HR .50, 95% CI 0.28-.88; p <.05) mortality on septic patients. However, In the subgroup, SB administration could only be found associated with improved hospital (HR .44, 95% CI 0.20-.97; p <.05) survival in septic shock. Conclusion: SB administration treatment could reduce ICU and hospital mortality of septic patients with acute MLA. Meanwhile, it could also improve hospital survival in the subgroup of septic shock patients with acute MLA.

Reducing Dietary Acid With Fruit and Vegetables Versus Oral Alkali in People With Chronic Kidney Disease (ReDACKD): A Clinical Research Protocol.

Individuals with chronic kidney disease (CKD) can develop metabolic acidosis which, in turn, is associated with faster progression of CKD and an increased need for dialysis. Oral sodium bicarbonate (the current standard of care therapy for metabolic acidosis) is poorly tolerated leading to low adherence. Base-producing or alkalizing Fruit and vegetables have potential as an alternative treatment for metabolic acidosis as they have been shown to reduce acid load arising from the diet. This trial will evaluate the feasibility of providing base-producing fruit and vegetables as a dietary treatment for metabolic acidosis, compared with oral sodium bicarbonate. A 2-arm, open-label, dual-center, randomized controlled feasibility trial. Two Canadian sites: a nephrology clinic in Winnipeg, Manitoba, and a nephrology clinic in Halifax, Nova Scotia. Adult participants with G3-G5 CKD and metabolic acidosis. Participants will undergo baseline measurements and attend 5 study visits over 12 months at which they will have a measurement of feasibility criteria as well as blood pressure, blood and urine biochemistry, 5-repetition chair stand test (STS5), and questionnaires to assess quality of life and symptoms. Furthermore, participants fill out Automated Self-Administered 24-hour recalls (ASA-24) in the beginning, middle, and end of trial. A total of 40 eligible participants will be randomized 1:1 to either base-producing fruit and vegetables (experimental) group or sodium bicarbonate (control) group, beginning from a daily dose of 1500 mg. Using self-administered dietary assessments, lack of supervision over the consumption of study treatments and the possible disappointment of the control group for not receiving fruit and vegetables would be considered as limitations for this study. However, we are planning to undertake proper practices to overcome the possible limitations. These practices are discussed throughout the article in detail. This study will generate data on base-producing fruit and vegetables consumption as a dietary treatment for metabolic acidosis in CKD. The data will be used to design a future multi-center trial looking at slowing CKD progression in people with metabolic acidosis. This study is registered on clinicaltrials.gov with the identifier NCT05113641.

Analysing the effect of sodium bicarbonate and glycine air polishing on tooth surfaces with two different imaging methods.

The aim of this study was to compare two different imaging methods by assessing changes caused by sodium bicarbonate and glycine air polishing on the tooth surfaces. Fourteen single root teeth with exposed root surfaces were included into the study. The teeth were randomly divided into two groups: sodium bicarbonate and glycine group. Samples were scanned in a micro-computed tomography (micro-CT) and CAD/CAM (computer-aided design/computer-aided manufacturing) at baseline and then after air-polishing powder applications, the defect volume values were evaluated. There was a statistically significant difference between mean defect volume values that occurred after glycine and sodium bicarbonate air polishing evaluated with micro-CT and CAD/CAM (p < 0.05). After sodium bicarbonate air polishing, defect volume on enamel surface at maximum power and defect volume on the exposed root surface at medium power values calculated with CAD/CAM were higher. After glycine air polishing, defect volume values on both surfaces at medium power setting calculated with CAD/CAM were lower. Defect volume values on enamel surface at maximum power setting calculated with CAD/CAM were higher than calculated with micro-CT. We concluded that CAD/CAM cannot provide as accurate results as micro-CT. Glycine-based powder is less abrasive than sodium bicarbonate, especially on enamel surface. Lay Description: Micro-CT is a non-destructive imaging method with high resolution and allows to examine all tooth structures individually. CAD/CAM are systems that are widely used in dentistry today. Access to the device is easier than micro-CT. Intraoral scanners in CAD/CAM systems also provide non-destructive image scanning. The aim of this study was to compare two different imaging methods by assessing changes caused by sodium bicarbonate and glycine air polishing on the tooth surfaces. The results showed that because of the analyses made with CAD/CAM, similar results could not be obtained with micro-CT and cannot be used to evaluate the changes that occur after air polishing.

The comparison of decrease in mice mass preserved with formalin 4% and neutralize with sodium bicarbonate.

Anatomy studies require cadavers to study the human body. Generally in Indonesia, the dead human body will be buried. This causes problems because the decomposition process of a cadaver that is preserved with formalin will be delayed and it causes environmental pollution. The toxicity of formalin can be reduced by neutralizing the formalin. This study aimed to compare the decrease of mice mass that were preserved with formalin then neutralized with sodium bicarbonate and those that were not neutralized. This study used 18 mice (Mus musculus) which were divided into 3 groups. They were the control group (not given preservative), group preserved with 4% formalin, and group preserved with 4% formalin then neutralized with sodium bicarbonate. All groups of mice were buried for 6 weeks. The changes in mass were assessed with an analysis of the percentage loss in mass. Based on the results of this study, the formalin group had a greater percentage of total mass reduction than the neutralize group. The formalin group had a higher decomposition rate than the neutralizing sodium bicarbonate group. The effectiveness of reducing the concentration of formalin is similar with neutralize group. Therefore, it can be concluded that 4% formalin is recommended for use to accelerate the occurrence of decay and decrease in mass.

Effectiveness of sodium bicarbonate infusion on mortality for elderly septic patients with acute metabolic acidosis

Objective: This study aimed to explore the effectiveness of sodium bicarbonate (SB) infusion on mortality in elderly septic patients with acute metabolic acidosis (MA) and in other subgroups. Methods: Retrospective analysis of a large ICU database (MIMIC-IV) was performed. Elderly septic patients with acute MA were identified from MIMIC-IV. Propensity score analysis (PSA) was performed to explain for the baseline differences in the probability to receive SB or not. The marginal structural Cox model (MSCM) was developed to adjust for both baseline and time-varying confounding variables. The primary outcome was the ICU and hospital mortality. Results: A total of 869 elderly septic patients with acute MA were identified in this study, including 361 in the SB group and 508 in the non-SB group. In the PSA, SB infusion was not associated with reduced ICU (HR 0.82, 95% CI 0.62–1.10; p = 0.19) or hospital (HR 0.94, 95% CI 0.74–1.19; p = 0.60) mortality in overall elderly septic patients with acute MA. In the subgroup of severe metabolic acidosis, SB infusion could not improve the ICU (HR 0.82, 95% CI 0.62–1.10; p =0.19) and hospital (HR 0.94, 95% CI 0.74–1.19; p =0.60) mortality on elderly septic patients. However, In the subgroup of moderate metabolic acidosis, SB infusion could be found associated with improved ICU (HR 0.64, 95% CI 0.43–0.95; p <0.05) and hospital (HR 0.70, 95% CI 0.50–0.99; p <0.05) survival in elderly septic patients. In the MSCM, the results were similar with PSA. Conclusion: SB infusion could improve both ICU and hospital survival for elderly septic patients with acute metabolic acidosis.

Effectiveness of sodium bicarbonate and zinc chloride mouthwashes in the treatment of oral mucositis and quality of life in patients with cancer under chemotherapy.

AimThe purpose of the study is to evaluate the effectiveness of sodium bicarbonate and zinc chloride mouthwashes on oral mucositis and quality of life in patients undergoing chemotherapy.DesignThe present study was a randomized controlled trial study.MethodsOne hundred forty‐four patients with a cancer diagnosis were randomly assigned into three groups: sodium bicarbonate mouthwash (n = 48), zinc chloride mouthwash (n = 48) and placebo group (n = 48). The severity of mucositis and quality of life were examined blindly at the baseline and 3‐week follow‐up.ResultsThe grade of oral mucositis decreased at the end of the third weeks in the sodium bicarbonate and zinc chloride groups rather than the placebo group (p < .001). The severity of oral mucositis in the sodium bicarbonate and zinc chloride groups decreased from end of the first week until third week (p < .001). In addition, there was significant difference in the severity of oral mucositis among the groups at the end of the second (p = .014) and the third weeks (p < .001). Also, there was a statistically significant difference in quality of life scores between the sodium bicarbonate and zinc chloride mouthwash with the placebo group (p < .001).ConclusionZinc chloride and sodium bicarbonate mouthwashes were effective in treating and reducing the severity of oral mucositis, and subsequently improving quality of life in patients with cancer under chemotherapy. Therefore, we can recommend zinc chloride and sodium bicarbonate at the beginning of chemotherapy to improve oral health and promoting quality of life in these patients.

A Comparative Study of Sodium Bicarbonate and Hyaluronidase on Pain Perception, Anesthesia, and Akinesia during Peribulbar Anesthesia for Cataract Surgery

Background:An ideal anesthetic solution should provide good anesthesia and akinesia with minimal pain on injection.Aims:The aim of this study is to determine the effect on pain perception and efficacy of sodium bicarbonate over hyaluronidase in the local anesthetic mixture during peribulbar anesthesia.Settings and Design:A prospective, randomized, double-blind study.Materials and Methods:An independent observer labeled two injections as A (hyaluronidase 1500 IU in 30 mL of lignocaine) and B (7.5% sodium bicarbonate 1 mL in 30 mL of lignocaine). Group 1 was injected with injection A while Group 2 was injected with injection B. The visual analog scale (VAS) was used to determine the intensity of pain. Onset and degree of anesthesia and akinesia were recorded.Statistical Analysis:Computer software Microsoft Excel SPSS version 26 (Chicago Inc) for windows was used. The qualitative data and quantitative data were reported as proportions and mean ± (standard deviation), respectively. Chi-square test for proportions was used for the comparison of qualitative variables and unpaired Student's t-test was used to test the significance between quantitative variables. P < 0.05 was considered statistically significant. All P were two-tailed.Results:Out of 123 patients, 23 were excluded from the study. Hundred patients were divided into Group 1 and Group 2. The mean age in Group 1 was 64.92 ± 10.77 years while in Group 2 was 62.86 ± 11.17 years. The mean heart rate and mean systolic blood pressure in both groups were statistically insignificant. Group 2 experienced very less pain (mean pain score VAS = 5.12 ± 1.17) as compared to Group 1 (mean pain score was 7.16 ± 1.09) and the difference between both the groups was found to be statistically significant. There was a significant difference in the onset of anesthesia in both groups (P = 0.001). In the sodium bicarbonate group, the onset was faster. The onset of akinesia was better in Group 1 (4.76 ± 2.06 min). Grading of akinesia was better in Group 1.Conclusion:Sodium bicarbonate reduces pain on injection in peribulbar anesthesia and also results in a quicker onset of anesthesia.