Mean Bilirubin Research Articles

Neonatal Jaundice Risk Factors and Multidirectional Intensive Phototherapy Management at Azadi Teaching Hospital in Kirkuk City

Background: A common illness in infants, neonatal jaundice is caused by high bilirubin levels in the first few days of life, which results in yellowing of the skin and eyes. Aim: This study aims to explore neonatal jaundice risk factors and assess the efficacy of multidirectional intensive phototherapy management at Azadi Teaching Hospital in Kirkuk City. Patients and Methods: In this retrospective cross-sectional study spanning from April 1st, 2021, to October 1st, 2021, a total of 497 newborns were examined. Jaundiced neonates underwent intensive phototherapy utilizing the Bilisphere 360 system, which featured a chamber with 16 cylindrical, blue TL 20W/52 fluorescent tubes. The newborns were positioned on a gauze hammock suspended at the chamber's center, illuminated on all sides. Results: A study found that neonatal jaundice affects 50.70% of studied neonates, primarily in the 16-21-day age group, with males accounting for 57.95% of the sample. 94.84% of neonates experience jaundice due to ABO blood group incompatibility and 88.10% due to Rh incompatibility. Additionally, 77.78% of term deliveries are associated with jaundice. Infants with jaundice have higher Thyroid Stimulating Hormone (TSB) and Thyroid Stimulating Hormone (TSH) levels and a younger mean age compared to non-jaundiced infants. Bilisphere 360 proves significantly more effective in the critical 12 to 48 hours after admission, with a mean total bilirubin of 10.71 ± 1.01 mg/dl compared to 14.65 ± 1.71 mg/dl for Neonatal Exchange Transfusions (P-Value: 0.001). Factors like blood group incompatibility, labor duration, and birth weight influence TSB levels in jaundiced neonates. The Bilisphere 360 method is found to be more effective in managing neonatal jaundice than Neonatal Exchange Transfusions in reducing total bilirubin levels.

ThP5.10 - Post ERCP Pancreatitis at a Tertiary Center - A Retrospective Incidence and Causal Analysis

Abstract Background Incidence of Post Endoscopic Retrograde Cholangio-Pancreatography (ERCP) Pancreatitis (PEP) varies between 3.5% and 9.7% as per the 2014 meta-analyses. Our aim was to evaluate the incidence, perform a causal analysis and gauge the financial implications of PEP in our hospital for general surgical patients to help optimise the utilisation of resources. Methods All General Surgical patients who had ERCP between 01/10/2022 and 31/03/2023 were included in the analysis. A successful ERCP was defined as cannulation of the biliary tree. The digital patient records were analysed and collected onto a master datasheet. They were divided into PEP and non-PEP groups. Results A total of 131/155 attempted ERCPs were successful. Of these 131, 13 (9.92%) developed PEP. Females were predominantly affected. Three out of six patients (50%) undergoing ERCP for malignant biliary obstructions developed PEP. Elective ERCPs (15% vs 6.5%) and higher mean bilirubin levels >= 134.92 µmol/L posed a greater risk of developing PEP (p-value=0.021). The mean hospital stay was 3.5 days longer (2-49 days) in the PEP group. The total extra cost to the NHS ranged from £20,475 - £35,763 over 6 months. Conclusion Patients with gallstone disease should receive prompt cholecystectomy in adherence to NICE guidelines to reduce the risk of gallstone-related problems and ERCP need. This in turn would lead to a reduction in PEP and positively affect the financial implications on the NHS. We also recommend a randomised control trial for patients with grossly deranged liver function tests to compare ERCP with laparoscopic cholecystectomy and common bile duct explorations combined.

Comparison of Bilirubin Level in Term Infants Born by Vaginal Delivery and Cesarean Section Delivery

Background: Given the overriding importance of neonatal jaundice and scarcity of studies on the role of route of delivery on its occurrence, this study aimed to investigate the association between neonatal bilirubin level and the route of delivery (i.e., normal vaginal delivery [NVD] and cesarean section [CS]). Methods: This prospective, cross-sectional study was conducted in 2012- in Accadmic hospital of medical faculty of balkh university Afghanistan, in all term infants, who met the inclusion criteria was serum bilirubin level was measured by the bili-test device between the second and seventh days after birth. In cases with skin bilirubin level>5 mg/dl, serum bilirubin was also checked. Results: A total of 182 neonates were enrolled in the study, 56% of whom were male. The mean bilirubin levels in the NVD and CS groups were 9.4±2.9 mg/dl and 9.8±3.4 mg/dl, respectively (P=0.53). Additionally, comparison of the mean bilirubin levels between the two groups based of demographic characteristics demonstrated no significant differences. Conclusion: This study showed no significant correlation between neonatal jaundice in term infants and the route of delivery.

435 Post ERCP Pancreatitis at a Tertiary Centre - a Retrospective Incidence and Causal Analysis

Abstract Background Post Endoscopic Retrograde Cholangio Pancreatography (ERCP) pancreatitis (PEP) is a serious and potentially life-threatening complication of ERCP. The overall incidence of PEP varies between 3.5% and 9.7% as per the recent meta-analyses in 2014. We aim to evaluate the incidence of PEP, conduct a causal analysis and financial implications at our hospital for general surgical patients. Method All General Surgical patients who had ERCP done between 01/10/2022 and 31/03/2023 were included in the analysis. The patient records on TrakCare® were analysed for demographic details, admission records, ERCP details, pre-procedural laboratory values and length of stay. The successful ERCPs defined as cannulation of the common bile duct were divided into the PEP and the non-PEP groups. Results A total of 155 patients had ERCP attempted but only 131 were successful. Of these 131, 13 (9.92%) developed PEP. Females in their 60s were predominantly affected. Three out of six patients undergoing ERCP for malignant biliary obstructions were affected (50%). Patients with grossly deranged Liver Function Tests (mean bilirubin levels >=134.92µmol/L) had a higher risk of developing PEP (p-value=0.021). The mean overall hospital stay was 3.5 days longer (2-49 days) for patients who developed PEP costing an extra £20,475 - £35,763 over 6 months to the NHS. There were no mortalities recorded. Conclusions Patients with gallstone disease should receive prompt cholecystectomy adhering to NICE guidelines to reduce the risk of developing gallstone-related complications. This in turn would lead to a reduction in PEP and positively affect the financial implications for the NHS.

Cytokine adsorption in patients with acute-on-chronic liver failure (CYTOHEP): A single center, open-label, three-arm, randomized, controlled intervention pilot trial.

To investigate the efficacy of bilirubin reduction by hemoadsorption with CytoSorb® in patients with acute-on-chronic liver failure (ACLF) receiving continuous renal replacement therapy (CRRT). A prospective, randomized, single-center, open-label, controlled pilot trial. Patients with ACLF, acute kidney injury, and serum bilirubin ≥5 mg/dL were assigned 1:1:1 to one of three study groups (CRRT with or without hemoadsorption, no CRRT). In the hemoadsorption group, the CytoSorb adsorber was incorporated into the CRRT system, replaced after 12, 24, and 48 h, and removed after 72 h. The primary endpoint was the serum bilirubin level after 72 h. CYTOHEP was terminated early due to difficulties in recruiting patients and ethical concerns. Three of 9 patients (33%) were treated in each group. Comparing the three groups, mean bilirubin levels after 72 h were lower by -8.0 mg/dL in the "CRRT with hemoadsorption" group compared to "CRRT without hemoadsorption" (95% CI, -21.3 to 5.3 mg/dL; p = 0.17). The corresponding mean difference between "CRRT without hemoadsorption" and "no CRRT" was -1.4 mg/dL (95% CI, -14.2 to 11.5 mg/dL; p = 0.78). Comparing "CRRT with hemoadsorption" and "no CRRT," it was -9.4 mg/dL (95% CI, -20.8 to 2.1 mg/dL; p = 0.0854). Only 1/9 patients (11%, "no CRRT" group) survived day 30 after study inclusion but died on day 89. IL-6, liver function parameters, and clinical scores were similar between the study groups. CYTOHEP failed to demonstrate that extracorporeal hemoadsorption combined with CRRT can reduce serum bilirubin in ACLF patients with acute kidney failure.

Assessments at week 2 and 3 in Term Newborns Diagnoses with Prolonged Jaundice

Introduction: Jaundice is one of the most common problems at neonatal period and seen in 60-70% of all newborns at first days of life. Prolonged jaundice is defined as hyperbilirubinemia persisting at the end of week 2 in term newborns. In this study, we reviewed term newborns diagnosed with prolonged jaundice. It was aimed to demonstrate delaying laboratory evaluations for a week in infants with favorable clinical presentation can prevent unnecessary tests in majority of newborns. Materials and methods: The study included full-term newborns who presented after day 14 of life and diagnosed with prolonged jaundice at neonatology outpatient clinic of Health Sciences University, Keçiören Teaching and Research Hospital in 2016. Overall, 336 infants with prolonged jaundice were screened. The infants with congenital anomaly, those with findings of sepsis or severe infection, those with history of intrauterine infection, those with history of acholic stool and those with no available data were excluded. In 180 patients included, clinical evaluations, bilirubin levels and advanced test results were assessed at baseline and weekly follow-up. Findings: Of the infants included, 51.7% were boys while 48.3% were girls. The most common blood type was A Rh (+). There was ABO incompatibility alone in 24 infants (14.2%), Rh incompatibility alone in 6 infants (3.5%) and ABO plus Rh incompatibility in 3 infants (1.2%). In 130 infants, total bilirubin was studied on both week 2 and 3. At week 3, total bilirubin value was ≥10 mg/dl in only 36 infants (27.7%) while it was decreased below 10 mg/dL in 94 infants (72.3%). Urinary tract infection (UTI) was detected in 7 of 38 infants with available tests at week 2. Two of 6 infants with UTI had other clinical signs of UTI. Mean total bilirubin value was 17.9 mg/dL in 5 infants. A significant correlation was found between UTI and vomiting, breastfeeding and feeding pattern (p

Improvement in Thrombocytopenia after Direct Acting Anti-Viral (DAA)Therapy in Patients with Hepatitis C Virus-Related Chronic Liver Disease in Pakistani Population-A Single Centered Study

Background: Hepatitis C Virus (HCV) infection remains a significant global health challenge, often leading to chronic liver diseases such as cirrhosis and associated complications like thrombocytopenia. Directly acting antivirals (DAAs) have revolutionized HCV treatment due to their high efficacy and favorable safety profiles but the impact on thrombocytopenia, particularly in the Pakistani population, has been less studied. Objective: This study aimed to evaluate the effects of DAA therapy on platelet count and other laboratory parameters in chronic HCV patients with thrombocytopenia in Pakistan and to establish correlations between treatment outcomes and baseline laboratory values. Methods: A retrospective observational study was conducted at the Sindh Institute of Urology and Transplantation from January 2018 to December 2022. Patients with chronic HCV genotype 3a infection, compensated cirrhosis, and a baseline platelet count of less than 150 × 10^9/L were included. Exclusion criteria encompassed decompensated liver disease, liver cancer, and other specific conditions. The treatment regimens were Sofosbuvir plus Daclatasvir or Velpatasvir plus Ribavirin over three months. Parameters such as complete blood counts, serum creatinine, liver enzymes, and Child-Turcotte-Pugh (CTP) and Model for End-Stage Liver Disease (MELD) scores were recorded at baseline and post-treatment. Statistical analysis was performed using SPSS version 25, employing paired t-tests and Pearson correlation coefficients. Results: A total of 195 patients were studied, with a mean baseline platelet count of 100.7 × 10^9/L, which significantly increased to 122.2 × 10^9/L post-treatment (p < 0.001). Improvements were also noted in mean serum creatinine (0.96 mg/dL to 0.87 mg/dL; p = 0.009), total bilirubin (1.6 mg/dL to 1.2 mg/dL; p < 0.001), liver enzymes (ALT from 63.9 IU to 45.9 IU; p < 0.001 and AST from 86.8 IU to 59.5 IU; p < 0.001), and MELD scores (11.5 to 9.3; p < 0.001). Hemoglobin levels and total leukocyte counts also showed significant improvements. Conclusion: DAA therapy significantly improves platelet counts and other laboratory parameters in chronic HCV patients with thrombocytopenia, suggesting a positive impact on liver function and patient management. This study highlights the importance of DAAs in the therapeutic regimen for HCV in the Pakistani population, contributing to better clinical outcomes and healthcare practices.

Investigation of the Effect of Therapeutic Plasma Exchange for TAFRO Syndrome: A Pilot Study.

TAFRO syndrome is a rare systemic inflammatory disorder with a fatal course. Nevertheless, a definitive treatment strategy has not yet been established. Anti-inflammatory therapies, including glucocorticoid treatment and immunosuppressants, have not been satisfactory. Therefore, new treatment options are needed for patients with TAFRO syndrome. The effectiveness of therapeutic plasma exchange (TPE) has mainly been reported in several case reports. In this case series study, we investigated the effect of TPE on TAFRO syndrome. We reviewed six consecutive cases with TAFRO syndrome treated at Shinshu University Hospital. All of them underwent TPE. A significant improvement in mean blood pressure, albumin, total bilirubin, and C-reactive protein was observed after TPE. Furthermore, early TPE treatment was suggested to have an impact on the prognosis. More intensive studies are needed to emphasize the overall conclusion obtained that TPE can be an effective/acceptable treatment option for TAFRO syndrome.

Point-of-Care Capillary Compared to Venous Bilirubin Measurement in Neonates

AbstractWe aimed to evaluate the agreement between the point-of-care (POC) capillary bilirubin measurement with POC venous samples and the reference laboratory measurement. We conducted a prospective comparative study, including neonates ≥ 34 weeks of gestational age, and ≥ 72 h of age. The agreement between POC (Calmark Neo-Bilirubin, Sommargatan, Karlstad, Sweden) capillary, POC venous, and laboratory venous bilirubin was examined with the Bland–Altman plot and the Passing-Bablok regression analyses. The mean bilirubin was 13.54 (2.79) mg/dL in the POC capillary samples, 13.45 (2.69) mg/dL in the POC venous samples, and 12.68 (2.33) mg/dL in reference samples. Bland–Altman plots showed optimal agreement between the POC capillary and venous methods, and with the reference venous method. The bias between the POC capillary and venous methods was 0.094 [levels of agreement (− 3.118)− 3.306], between the POC capillary and the reference venous methods 0.865 [levels of agreement (− 2.283)− 4.014], and between the POC venous and the reference venous methods 0.771 [levels of agreement (− 1.814)− 3.357]. The POC capillary and venous bilirubin levels were in optimal agreement with each other, and with the reference venous measurements, supporting the POC Calmark Neo-Bilirubin capillary measurement as an alternative for a less-invasive, more rapid evaluation of bilirubin.

Validity of BiliDx as a point-of-care bilirubin measurement device to diagnose and monitor neonatal jaundice at Muhimbili National Hospital, an observational study

BackgroundNeonatal jaundice is a condition caused by elevated levels of bilirubin in the bloodstream. Laboratory determination of serum bilirubin concentration by total serum bilirubin (TSB) test is still considered as gold standard for clinical guidance and practice. In developed countries, diagnosis of neonatal jaundice is shifting towards point-of-care medical devices. BiliDx is a device developed to allow a fast, blood-based determination of bilirubin levels at the point of care. This study aimed to determine the accuracy of the BiliDx device relative to a standard laboratory total serum bilirubin to diagnose and monitor jaundice among neonates admitted at Muhimbili National Hospital (MNH).Material and methodologyThis was a prospective hospital-based observational study conducted at the Neonatal Ward – MNH, Dar-es-Salaam, Tanzania from November 2022 to January 2023. A total of 180 neonates admitted at the neonatal ward with jaundice and whose parents consented were enrolled in the study. Blood samples were collected; 2 ml of venous blood into the vacutainer bottle for standard laboratory measurement of total serum bilirubin (TSB) and 25µL blood collected into a transfer pipette tube and applied to BiliDx. STATA version 15.1 was used for data analysis.ResultsOut of 180 neonates, 39.4% (71/180) had birth weight between 1500 − 2499.9 g, approximately 2/3rd (120/180) were preterm, 92/180 (51.1%) were males and 100/180 (55.6%) were undergoing phototherapy treatment the moment sample taken. The mean bilirubin concentration was 92 mmol/l for BiliDx and 118 mmol/l for standard laboratory TSB. The minimum and maximum values obtained with BiliDx were, 3.4 and 427.5 mmol/l respectively, compared with 10.7 and 382.1 mmol/l using standard laboratory TSB. A linear relationship and correlation coefficient of 0.8408 (p = 0.000) between BiliDx and standard laboratory TSB was found. The regression analysis showed the presence of constant error [coefficient of BiliDx/slope = 0.91, 95% CI (0.82–0.99), p = 0.000] and random error exclusively [coefficient of constant/y-intercept = 48.52, 95%CI (37.70-59.34), p = 0.000]. The Bland–Altman plot showed an acceptable mean difference of 39.1mmol/l, limits of agreement of -48.3mmol/l to 126.4mmol/l, and 179 points (179/180 = 99.4%) lying inside the limits of agreement.ConclusionThe results support the use of BiliDx for rapid and accurate testing of elevated levels of bilirubin in the bloodstream among neonates since 99.4% of the differences between BiliDx and standard laboratory TSB lie between the lines of agreement.

Spectrum of Liver Injury in Dengue Fever: Cause or Effect of Severe Dengue?

The study aimed to determine if deranged liver function tests (LFTs) can predict severe dengue or mortality. It included 135 dengue patients, with a mean age of 30.9 ± 12.09 years. Among the patients, 82 (60.7%) were under 30 years of age. Nearly half of the patients (64, 47. 4%) had some degree of liver damage indicated by deranged LFTs, 27 (42.1%) had elevated alanine transaminase (ALT), 7 (10.9%) had increased bilirubin, and 30 (46.9%) had high values of alkaline phosphatase (ALP). However, only elevated ALP levels were positively correlated with mortality (Pearson's R = 0.282, p = <0.05). The mean bilirubin was 11.711 ± 8.602 umol/l, and the mean values of ALT and ALP were 107 ± 240 and 113.571 ± 59.91 IU/L, respectively, which were higher than the normal. The study findings suggested that hepatic derangement is a common occurrence in dengue patients, and increased ALP levels could be an indicator of a higher risk of mortality. These findings can help improve patient care by identifying the potential risk factors for mortality. Key Words: Dengue, Liver function tests, Alanine transaminase, Alkaline phosphatase.

Predictability of Umbilical Cord Serum Bilirubin in Estimating the Risk of Hyperbilirubinemia in Term Neonates with ABO Incompatibility- A Prospective Cohort Study

Introduction: Neonatal hyperbilirubinemia is a significant cause of morbidity among term neonates. Delayed follow- up of newborns may lead to considerable morbidity and encephalopathy. High bilirubin levels may necessitate exchange transfusion, especially in infants with ABO or Rh blood incompatibility. Measurement of Umbilical Cord Bilirubin (UCB) is an easily available, inexpensive and non invasive method to predict the development of hyperbilirubinemia in newborns. Aim: To determine the predictive value of UCB in estimating the risk of subsequent hyperbilirubinemia in term neonates with ABO incompatibility and to establish a UCB cut-off associated with the risk of hyperbilirubinemia development. Materials and Methods: This prospective cohort study was conducted at the Punjab Institute of Medical Sciences (PIMS) in Jalandhar, Punjab, India, from June 2022 to March 2023. A total of 113 term babies born to O+ mothers were included in the study. At the time of delivery, cord blood was drawn from the placental side of the cord for blood group, Direct Coomb’s Test (DCT), and serum bilirubin analysis. Infants were followed-up every 12 hours while inpatient and every 48 hours after discharge until day 5 for assessment of clinical jaundice. Significant hyperbilirubinemia was managed with phototherapy according to American Academy of Paediatrics (AAP) guidelines. The data was collected and subjected to statistical analysis using IBM Statistical Package for Social Sciences (SPSS) 20.0 software, with a significance level set at p-value &lt;0.05, utilising Receiver Operating Characteristic (ROC) curve analysis. Results: A total of 113 term neonates were enrolled in the study, of which 57 (50.4%) were females. The mean cord bilirubin level was 2.6±1.06 mg/dL. A total of 40 (35.3%) babies developed significant jaundice requiring phototherapy, with a mean highest bilirubin level of 15±3.2 mg/dL. Using a cord bilirubin level of ≥2.0 mg/dL, significant hyperbilirubinemia could be predicted with a sensitivity of 80%, specificity of 54%, positive predictive value of 57.97%, and negative predictive value of 75%. There was a positive correlation between cord bilirubin and postnatal serum bilirubin in the present study, as determined by ROC analysis {Area Under Curve (AUC) &gt;0.5}. Conclusion: The present study concluded that UCB is an important predictor of significant hyperbilirubinemia occurrence in newborns with ABO incompatibility.

The Prevalence and Outcomes of Hepatorenal Syndrome in Chronic Liver Disease Patients in a Tertiary Care Hospital

Hepatorenal syndrome (HRS) leads to a severe kidney injury leading to its eventual failure in the background of chronic liver disease. Objective: This research’s objective was to define the frequency of hepatorenal syndrome (HRS) in the background of cirrhosis and to find out the outcomes of the patients with HRS. Methods:This is a detailed prospective clinical series research. It was conducted in the Department of Medicine, Jinnah Postgraduate Medical Center (JPMC), Pakistan, from February 2020 to December 2020 after approval by the authorized review board. Jinnah Postgraduate Medical Center (JPMC). A sample size of 101 was calculated. The lab values including prothrombin time (PT), serum albumin, and chronic liver disease variations were established for confirmative diagnosis. Frequency tables were created for parameters to be determined (sex and Child-Pugh classification). The means and their SD of parameters of interest (age and weight) were calculated. Results:The demographic variables were the mean age of the patients was 62.5±10.2 and the mean bilirubin was 2.32 ± 2.3mg/dL. 68 (67.3%) of the patients had normal creatinine and 33 (32.7%) of the patients had raised serum creatinine. 2(10.5%) of the patients had a numerical score of 5-6, 13 (68.4%) of the patients had a total score of 7-9 and 4(21.1%) of the patients had 10-15 scores. Hepatorenal syndrome was detected in 11.9% of patients with cirrhosis, among whom 4 (33.3%) died. Conclusions:The hepatorenal syndrome is quite common in liver diseases and it needs to be assessed.

Single surface phototherapy with reflecting curtains versus double surface phototherapy in unconjugated neonatal hyperbilirubinemia in a tertiary care NICU

BACKGROUND Neonatal hyperbilirubinemia is treated with different modalities like single, double surface phototherapy and biliblankets. Reflecting curtains with single surface phototherapy is a cheaper and easy modality . So, this study was designed to compare the efficacy of single surface phototherapy with reflecting curtains [SSPRC] versus double surface phototherapy [DSP]. METHODS A prospective comparative study in 120 term neonates with unconjugated hyperbilirubinemia was conducted from July 2021 – Jan 2022 in Neonatal intensive care unit of College of Medical Sciences, Bharatpur. The study population was randomized to either SSPRC or DSP. The primary outcome was mean decrease and rate of decrease of bilirubin in subsequent 6 and 12 hours. Secondary outcome were duration of phototherapy and complications. The analysis was done using SPSS version 18.0. RESULTS Mean bilirubin level at 6 hours after starting phototherapy was 16.27 mg/dL vs 16.71 mg/dL, p=0.542 and at 12 hours 14.61 mg/dLvs 14.70 mg/dL, p= 0.428. Mean rate of decrease in SSPRC vs DSP was 1.63 mg/dL vs 1.81 mg/dL, p=0.154 at 6 hours, 3.29 mg/dL vs 3.82 mg/dL, p=0.39 at 12 hours. Mean duration of phototherapy was significantly lower in SSPRC 3.8 Vs 4.2 days, p=0.031.Complications were skin rashes 11.7% vs 16.7%, p=0.432 and change in frequency of stool 10.0% vs 8.3%, p=0.752. CONCLUSION Single surface phototherapy with reflecting curtain as double surface phototherapy is equally effective, reliable and successful in decreasing bilirubin in less duration with minimum complications. Therefore this technique can be of help where DSP is unavailable or unaffordable.

Evaluation of therapeutic effect of oral Ursodeoxycholic Acid on indirect hyperbilirubinemia in term neonates undergoing phototherapy: A randomized controlled clinical trial

Introduction and aims Phototherapy is the most common treatment modality of neonatal hyperbilirubinemia. We aimed to evaluate the therapeutic effect of oral Ursodeoxycholic Acid (UDCA) on indirect hyperbilirubinemia in term neonates undergoing phototherapy. Materials and methods This randomized controlled clinical trial was performed on 106 full-term neonates with jaundice who were admitted to the neonatal ward of 17 Shahrivar Hospital in Rasht, Iran. The neonates were randomly assigned to two groups of intervention (10 mg/kg UDCA+phototherapy) and control (phototherapy alone). Total serum bilirubin (TSB) was measured at the time of admission, during first 12, 24, and 48 hours after admission and at the time of discharge. The duration of hospitalization and side effects were also assessed in both groups. IBM SPSS Statistics for Windows, version 20 was used to analyze the data. Results Results showed that in the intervention group, 28 (52.8%) of neonates were boys with the mean age of 5.1±1.25 days. While, in the control group 29 (54.7%) of them were boys with the mean age of 5.19±2.26 days. Bilirubin levels in both groups decreased significantly after hospitalization (at 12, 24 and 48 hours) (P &lt;0.001). The mean of bilirubin at 12, 24 and 48 hours in the intervention and control groups were 17.1, 13.2, 10.2 mg / dl and 17.1, 14.2 and 11.3 mg / dl, respectively. At the time of discharge, TSB in the former compared to the latter group was significantly reduced (7.74± 1.39 vs. 8.67±1.35) (P = 0.001). In addition, the duration of hospitalization was considerably shorter in the intervention compared to the control group (P = 0.038) and no side effects were observed. Conclusions Administering UDCA plus phototherapy reduced TSB and length of hospital stay with proper safety and efficacy. Therefore, it seems that this combination can be an appropriate treatment modality in neonatal hyperbilirubinemia.

Associated Risks and Pathogenic Effects of Consumption of Calcium Carbide-Ripened Banana Before and/or During Pregnancy on Maternal and Neonatal Livers

Calcium carbide (CaC2) is a commonly used ripening agent, although its primary use is in welding. Use of CaC2 in ripening fruits is considered harmful because it contains traces of phosphorous and arsenic. Aim of this study was to investigate associated risks and pathogenic (biochemical and histological) effects of consuming CaC2-ripened banana as a meal, before and/or during pregnancy on maternal and neonatal livers of adult female wistar rats. 36 healthy-looking, nulliparous, adult female wistar rats weighing between 150-200g were utilized. Rats were divided into 2 groups namely Group A and Group B. Each group had 4 subgroups (A1, A2, A3 and A4) for Group A as well as (B1, B2, B3 and B4) for Group B. Rats in group A received CaC2-ripened banana blended into their meal before and during pregnancy while group B rats received the same meal during pregnancy only. Subgroups A1 and B1 (positive control) received a naturally ripened banana with 0% CaC2, subgroups A2 and B2 received 1% CaC2-ripened bananas whereas subgroups A3 and B3 received 2% CaC2-ripened bananas. Subgroups A4 and B4 received CaC2-ripened bananas (bought from the market) randomly. The two groups A and B had one common negative control group which did not receive any banana (CaC2-ripened or non-CaC2-ripened) blended meal. Liver enzyme assay for group A showed that the positive control subgroup (A1) had mean AST (26.00±2.00 iu/L), ALT (33.00±3.00 iu/L), albumin (3.80±0.20 g/dL), direct (conjugated) bilirubin (1.10±0.10 mg/dL), and total bilirubin (1.95±0.15 mg/dL). These values were not significantly different (p≥0.05) compared with their respective values in the negative control subgroup except for ALT (p&lt;0.05). Group B showed that subgroups B2, B3, and B4 had mean AST, ALT, albumin, direct bilirubin and total bilirubin values which were not significantly different (p≥0.05) compared with their respective values in the negative control subgroup. Histological findings confirm a damaging effect on the liver’s histoarchitecture of both mother and neonate. Consumption of CaC2-ripened banana before and/or during pregnancy has associated risks and pathogenic effects on maternal and neonatal livers.

Association between serum bilirubin and estimated glomerular filtration rate in diabetic patients with chronic kidney disease

Background and objectives: Hyperglycemia induces oxidative stress in diabetic patients by increasing reactive oxygen species production, which ultimately damage the cells and cause micro and macrovascular complications including diabetic nephropathy. Increased serum bilirubin level, within physiological range, can inhibit oxidative stress; thereby, preventing development of diabetic nephropathy. The aim of this study was to find out association between serum bilirubin and estimated glomerular filtration rate (eGFR) in diabetic patients with or without chronic kidney disease (CKD). Materials and method: Both male and female participants aged 30 to 60 years were enrolled in the study. Enrolled participants included healthy individuals (Group-1), diabetic patients without CKD (Group-2) and diabetic patients with CKD (Group-3). Clinical and biochemical parameters namely blood pressure, body mass index (BMI), fasting blood glucose (FBG), HbA1c, eGFR, serum bilirubin and spot urine ACR were measured by appropriate methods. Pearson’s correlation coefficient, ANOVA and multiple linear regression models were used to analyze the data. Result: Total 189 respondents were enrolled in 3 study groups. Each group consisted of 63 cases. Of the 63 cases in Group-3, 49 and 14 belonged to CKD stage 3 and stage 4 respectively. The mean (± SD) serum bilirubin levels of healthy individuals, diabetic patients without CKD and diabetic patients with CKD were 0.66 ± 0.31, 0.64 ± 0.21, 0.46±0.18 mg/dL respectively. Mean serum bilirubin was significantly low (p&lt;0.001) in diabetic patients with CKD compared to healthy and diabetics without CKD. A Stepwise multiple regression analysis using eGFR as an objective variable adjusted for risk factors as explanatory variables, showed that serum bilirubin (β=0.323, p&lt;0.001) was significantly associated with eGFR, in addition to age, BMI, HbA1c and urinary ACR. Conclusion: The study has demonstrated that low serum bilirubin level is associated with CKD in diabetic patients and it could be used as a simple marker for CKD in diabetics. IMC J Med Sci. 2024; 18(1):006. DOI: https://doi.org/10.55010/imcjms.18.006 *Correspondence: Tanzia Tahfim, Department of Biochemistry, Shaheed Monsur Ali, Medical College, Uttara, Dhaka-1230, Bangladesh. Email: tanzia.uamc@gmail.com

Classical Complement Inhibition By SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results from the Open-Label, Non-Randomized, Single-Dose Phase 1b Study

Background:Cold agglutinin disease (CAD) is a rare, chronic autoimmune hemolytic anemia characterized by complement-mediated hemolysis. The classical complement inhibitor sutimlimab, is the first approved pharmacotherapy for treating patients with CAD. The second-generation complement inhibitor SAR445088 (BIVV020) is a humanized monoclonal antibody that selectively inhibits the activated form of C1s (sutimlimab inhibits total C1s). Furthermore, SAR445088 contains mutations that increase FcRn binding, preventing its degradation and allowing it to be recycled back into the system, resulting in reduced drug clearance and a prolonged half-life, which may allow a longer dosing interval than that of sutimlimab. Aims:This Phase 1b open-label study evaluated the safety, tolerability, effect on hemolysis, and pharmacodynamics (PD)/pharmacokinetics (PK) of a single intravenous (IV) dose of SAR445088. The study aimed to assess the impact of SAR445088 on complement-mediated hemolysis to support proof of concept for SAR445088 as a treatment for patients with CAD. Methods:The study design included up to three single-dose cohorts with a maximum of six patients per cohort. SAR445088 was administered on Day 1 with follow-up visits from Day 2 to Day 71; end of study (EOS) visit was on Day 106. The first cohort received a dose of 30 mg/kg IV with decisions about the selection of the dose for the next cohort being based on safety, biomarker activity, and PD. In the second cohort, patients received a lower dose of 15 mg/kg IV; a third, higher-dose cohort was not enrolled. To be enrolled in the study, participants needed to be aged ≥18 years with a confirmed diagnosis of CAD and a hemoglobin level ≤11.0 g/dL at time of screening. The primary endpoint was assessment of safety, with secondary endpoints of hematologic biomarkers and PD/PK. Results:Twelve patients received a single IV dose of SAR445088 (n=6, 30 mg/kg; n=6, 15 mg/kg). Patients enrolled in the study were mainly female (91.7%, n=11) with a median age (range) of 69 (54-80) years, and median (range) hemoglobin at baseline was 9.60 (4.8-10.9) g/dL. There were no treatment-emergent serious adverse events (AEs), discontinuations or deaths reported in the study. Fifty-eight treatment-emergent AEs (TEAEs) were reported in 11 patients (91.7%). There was one reported pre-treatment severe AE (Grade 3) of hemolytic anemia in a patient in the 15 mg/kg IV cohort which began prior to treatment and continued during the treatment period; the remainder of TEAEs were mild or moderate in severity (Grade 1 or 2). The most frequently reported AE was hematuria. No serious infections, meningococcal infections, hypersensitivity, or thromboembolic events were reported. Nine patients (n=4, 30 mg/kg IV cohort; n=5, 15 mg/kg IV cohort) reached an increase of hemoglobin ≥1.5 g/dL from baseline to Day 106 (EOS visit); eight patients (n=4 for both cohorts) reached an increase in hemoglobin &amp;gt;1.0 g/dL from baseline to Day 15 (Figure A). Total mean bilirubin decreased by Day 1 and this was sustained to Day 106 (EOS visit; Figure B).The decrease was more pronounced in the 30 mg/kg IV cohort. Improvements in clinical markers correlated with sustained reductions in CH50 in both treatment cohorts. Reductions in mean percent classical complement pathway (CP) activity were noted 1 hour after a single dose of 30 or 15 mg/kg IV, followed by gradual rebound of CP activity over the 15-week study period. Conclusion:SAR445088 was generally well tolerated; no safety concerns were identified in patients with CAD. A single IV dose of SAR445088 led to classical complement inhibition, control of hemolysis, and improvement in anemia, which was sustained for 15 weeks.

The role of high serum bilirubin as a predictor of complicated appendicitis: a retrospective cohort study

Introduction: An appendectomy is one of the most common emergency surgeries. The delay in diagnosis and treatment of appendicitis can lead to complicated appendicitis. The definitive predictive factor that can diagnose complicated appendicitis is still lacking. The authors aim to assess the role of high serum bilirubin level as a predictor of complicated appendicitis. Methods: A retrospective cohort study was conducted among patients with acute appendicitis (AA) between March 2017 and March 2018. Appendicitis cases diagnosed with the help of the Alvarado score undergoing surgery were taken in study and based on the histopathological report, the cases were classified into two groups: uncomplicated and complicated. Preoperatively, biochemical parameters like increased white blood cell count (&gt;11000/cubic millimeter), and level of serum bilirubin &gt;1.4 mg/dl were studied. Informed written consent for the study was taken from the patients with AA. A χ 2 test was applied for the association between categorical variables. Statistical analysis was done with a statistical package for the social sciences (SPSS) version 20; P-value less than 0.05 was considered statistically significant. Results: A total of 100 patients were enrolled in the study with a mean age of 31.2±18.3 years, and 60% were male. Seventy-four (74%) had uncomplicated appendicitis and 26 (26%) had complicated appendicitis. Mean bilirubin was 1.2±0.8 mg/dl in uncomplicated and 1.8±0.8 mg/dl in complicated groups (P &lt;0.05). The sensitivity and specificity of hyperbilirubinemia as a predictor of complicated appendicitis were 50 and 78.38%, respectively. Conclusion: The study revealed that patients with AA and a higher serum bilirubin level have a higher risk of having complicated appendicitis. Serum bilirubin level helps to predict complicated appendicitis and thus plan for timely and appropriate management. Thus, the study concludes that bilirubin should be used together with clinical examination and other laboratory investigations in the assessment of patients with suspected AA.

Correlation between Bilirubin Elimination with the Cytokine Adsorber CytoSorb® and Mortality in Critically Ill Patients with Hyperbilirubinemia

Introduction: Hyperbilirubinemia is often the first evidence for any kind of liver disorder and over one-third of all patients in intensive care units (ICU) show elevated bilirubin concentrations. In critically ill patients, high concentrations of serum bilirubin are correlated with a poor outcome. Therapies to lower bilirubin concentrations are often just symptomatically and their effect on the patients’ outcome is hardly evaluated. Therefore, this study investigates whether the extracorporeal elimination of bilirubin with the cytokine adsorber CytoSorb^® (CS) reduces mortality in patients with hyperbilirubinemia. Methods: Patients with bilirubin concentrations >10 mg/dL at the ICU were screened for evaluation from 2018 to 2020. Patients with kidney replacement therapy and older than 18 years were included. Patients with continuously decreasing bilirubin concentrations after liver transplantation or other liver support systems (i.e., Molecular Adsorbents Recirculating System [MARS^®], Advanced Organ Support [ADVOS]) were excluded. CS therapy was used in clinical routine and was indicated by the treating physicians. Statistical analysis was performed with IBM SPSS statistics utilizing a multivariate model. Primary outcome measure was the effect of CS on the 30-day mortality. Results: Data from 82 patients (mean Simplified Acute Physiology Score [SAPS] II: 74 points, mean bilirubin: 18 mg/dL, mean lactate: 3.7 mmol/L) were analyzed. There were no significant differences in patients with and without CS treatment. The multivariate model showed no significant effect of CS therapy (p = 0.402) on the 30-day mortality. In addition, a significant effect of bilirubin concentration (p = 0.274) or Model for End-Stage Liver Disease score (p = 0.928) on the 30-day mortality could not be shown. In contrast, lactate concentration (p = 0.001, b = 0.044) and SAPS II (p = 0.025, b = 0.008) had significant impact on 30-day mortality. Conclusion: The use of CS in patients with hyperbilirubinemia did not result in a significant reduction in 30-day mortality. Randomized and controlled studies with mortality as primary outcome measure are needed in the future to justify their use.