Prospective Randomized Parallel-group Study Research Articles

Safety and efficacy of remimazolam compared with midazolam during bronchoscopy: a single-center, randomized controlled study

Although remimazolam is an ultra-short-acting benzodiazepine with a shorter elimination half-life and faster recovery time than midazolam, studies evaluating its safety and efficacy during bronchoscopy are limited. This study aimed to compare the safety and efficacy of remimazolam with those of midazolam for bronchoscopy. This prospective randomized parallel-group study was conducted at a single institution. The primary outcome was the time from the end of the procedure to full alertness. Other procedural time parameters, satisfaction profiles, and adverse effects were thoroughly evaluated. The time taken to reach peak sedation and the time from the end of the procedure to full alertness was significantly shorter in the remimazolam group than in the midazolam group (median [interquartile range], 2 min [1–4] vs. 3 min [2–5], P = 0.006; and median, 2 min [1–5] vs. 5 min [1–12], P = 0.035, respectively). In patients with non-biopsy procedures (n = 79), participant satisfaction was significantly higher in the remimazolam group than in the midazolam group (median rated scale, 10 vs. 7, P = 0.042). Physician satisfaction and willingness to repeat the procedure were similar between groups. Although the incidence of adverse effects was similar between the groups and there was no significant difference, the midazolam group had a higher antidote administration rate than the remimazolam group (15.7% vs. 4.1%, P = 0.092). Remimazolam is effective and safe for achieving adequate sedation, with a shorter onset time and faster neuropsychiatric recovery than midazolam. It may be a new option for sedation during bronchoscopy.Trial registration: The trial registration number is NCT05994547, and the date of first registration is 16/08/2023.

Randomized contralateral comparison of visual outcomes following implantation of two monofocal aspherical intraocular lenses after cataract surgery.

To compare optical and visual performances of two one-piece aspherical implanted intraocular lenses (IOLs) following phacoemulsification cataract surgery in a contralateral eye study. In this prospective randomized parallel-group study, 25 patients with bilateral age-related cataract were implanted in one eye with the EnVista IOL (MX60, Bausch & Lomb Corporations, Rochester, NY, USA) and the Acrysof IQ IOL (Acrysof IQ SN60WF, Alcon Surgical Laboratories, Fort Worth, TX, USA) in the other eye. Uncorrected and corrected distance visual acuity (UDVA, CDVA), refractive status, higher-orders aberrations (HOAs) in 5 and 6mm pupil size, contrast sensitivity (CS) with and without glare, color vision status, and patient satisfaction were assessed in the two eyes at 1 and 3months after surgery. There was no significant difference in CDVA (P > 0.99), UDVA (P = 0.46), spherical equivalent refractive error (P = 0.63), CS with and without glare across different spatial frequencies, color vision, and root mean square (RMS) of aberrometric values between the two IOLs after 3-month follow-up. Spherical aberration with 5 and 6mm pupil sizes (P = 0.02) and horizontal coma with a 6mm pupil size (P < 0.001) were lower with the EnVista IOL. Patient's satisfaction showed no cases of dissatisfaction, and most patients were highly or moderately satisfied with both IOLs. The visual and optical performance of eyes implanted with the EnVista IOL or the Acrysof IQ IOL was similar, although the aberration profile differed.

Optimize Initial Freezing Time of Transbronchial Cryobiopsy for the Diagnosis of Interstitial Lung Disease: A Prospective Randomized Parallel Group Study

Background: Transbronchial cryobiopsy (TBCB) is increasingly being identified as a potential alternative for the diagnosis of interstitial lung disease (ILD). The specimen size of TBCB is positively related to the freezing time. However, the proper initial freezing time for the clinical application of TBCB in ILD remains unknown. Methods: A prospective randomized parallel group study was employed to investigate ILD patients with unclear diagnosis, who were admitted to the First Affiliated Hospital of Guangzhou Medical University from May 2019 to October 2020 and required TBCB. All patients were randomly divided into 4 groups according to the different freezing times of TBCB: 3 s, 4 s, 5 s, and 6 s groups. All operations were performed under intravenous anesthesia with endotracheal intubation, 60–65 bar pressure of freezing gas source, and 1.9-mm cryoprobe. Compare differences among groups in specimen size, complications, pathological diagnosis efficiency, and multidisciplinary discussion (MDD) diagnostic efficiency. Results: A total of 100 patients were recruited and randomly assigned into 4 groups (n = 25 each group). The specimen sizes of TBCB in ILD were positively correlated with the freezing time (r = 0.639, p < 0.05). None of the patients experienced Grade 3 severe bleeding. Pneumothorax occurred in 1 patient in the 4 s, 5 s, and 6 s groups, respectively. The diagnostic yield of MDD in the 3 s, 4 s, 5 s, and 6 s groups were 64%, 88%, 88%, and 96%, respectively (p < 0.05), but showing no significant differences among 4 s, 5 s, and 6 s groups. Conclusions: The specimen size and diagnostic efficiency of TBCB in ILD increased with a longer freezing time. When the freezing gas pressure is 60–65 bar, we recommended 4 s as the initial freezing time of TBCB, and this time is associated with high diagnostic efficiency and low incidence of complications.

The effect of patient training of the fundamentals of medical knowledge on the effectiveness of controlling cardiovascular risk factors

Abstract A prospective randomized parallel-group study was performed to assess the effectiveness of group and individual educational training of patients of the fundamentals of medical knowledge to control risk factors. The study included 365 patients with high and very high cardiovascular risk; 150 had group training; 150 had individual training; 65 were a control group, follow-up period was 3 years. Blood pressure, body mass index (BMI), fat to muscle ratio (bioimpedance method, Body Composition Monitor BF511), physical activity (Walking style III pedometer), blood lipids, glucose, glycosylated hemoglobin, quality of life (SF-36 Health Status Survey questionnaire), eating habits, and compliance to medical therapy (Morisky-Green questionnaire) were evaluated before and after completion of the training. The composite endpoint was assessed (myocardial infarction, stroke, cardiovascular death, hospitalizations due to worsening of heart failure, urgent revascularization). Educational hours were the same in both groups, but in the “Individual group” patients had “face to face” visits with a medical specialists. All patients kept an individual diary. Statistical processing was performed using the SPSS 17 (IBM) package. Results In both training groups, a significant decrease in blood pressure and an increase of patients with the target blood pressure were found. After completing the educational course, the level of compliance to drug treatment in the “group training” had scored of 3.2 [1.5–3.5]; 3.5 [2.5–3.75] in the “individual training” group, and 2.0 [1.0–3.0] in the control group. Initially, the number of patients with the targeted blood pressure level was 63 (42.0%) and 67 (44.6%) persons in the “group training” and “individual training” groups; this parameter after training completion was 134 (89.3%, p=0.0001) in “group training” and 121 (80.6%, p=0.0001) in “individual training”. Patients undergoing “group training” did not have their blood lipids changed significantly. In the course of “individual training”, statistically significant decreases in total cholesterol by 21.1% (p=0.031), LDL cholesterol by 20.1% (p=0.04) and an increase in HDL cholesterol by 11% (p=0.03) were observed. A significant decrease in BMI (by 7.1%, p=0.011) and fat tissue content (10.2%, p=0.013) were observed only after “individual training”. Eating habits and smoking rate did not change significantly in the groups. An increase in physical activity was detected only in “individual training” group. Risk of cardiovascular events was lower “individual training” group (OR-0,32; CI 95% 0,12–0,84; p=0,02). Conclusion Both individual and group educational courses did not lead to a change in eating habits, but had significant effect on blood pressure. More significant effect of individual training compared to group training was found on blood lipids, physical activity and quality of life. A decrease in cardiovascular events was noted only in the “individual training” group. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): L.T. Mala National Institute of Therapy NAMSU

The efficacy of secondary prevention programs with remote support in coronary heart disease patients with abdominal obesity

To assess the impact of 2 preventive counselling programs with subsequent remote support in CHD patients with concomitant obesity. A prospective randomized parallel-group study in 120 stable CHD patients hospitalized for elective coronary revascularization who were from 40 to 65 years old and had concomitant obesity. Patients were randomized (1:1:1) into 3 groups (n=40 each). Before discharge, Groups 1 and 2 received a single-session comprehensive counselling with focus on diet followed by remote counselling by phone (Group 1) or via text messages (Group 2). Remote counselling was delivered weekly (Months 1-3) and then monthly (Months 4-6). Group 3 received only standard advice from their attending physicians. The patients were followed for 12 months with assessment of adiposity measures, self-reported dietary patterns, physical activity (IPAQ questionnaire), smoking status, blood pressure (BP), fasting blood glucose, lipids and C-reactive protein (CRP) levels, as well as of clinical events. At 1 year of follow-up, the patients from both intervention groups showed a marked improvement of several risk factors including obesity: the body mass index was reduced by 1.48±0.13 kg/m² in Group 1 and by 1.53±0.18 kg/m² in Group 2; the waist circumference went down by 7.62±0.49 and by 7.41±0.74 cm, respectively; the height-normalized fat mass decreased by 4.66±0.40 kg and 5.98±0.63 kg, respectively (all P values are &lt;0.01 vs corresponding changes in the control group). These changes were coupled with more healthy dietary patterns and less sedentary lifestyles in both intervention groups: the proportion of patients with low activity level fell from 87.5% to 2.5% in Group 1 and from 80% to 10% in Group 2 (both p values &lt;0.01 vs control). In Group 1, BP decreased by 18.08±2.20 mmHg (systolic) and 8.56±1.61 mmHg (diastolic); both р values &lt;0.01 vs Group 3. In Group 2 systolic BP dropped by only 11.95±2.50 mmHg (non-significant) and diastolic BP by 6.33±1.52 mmHg (р&lt;0.05 vs control). The proportion of smokers went down from 30% to 5% in Group 1 and from 22.5% to 0% in Group 2 (both p values &lt;0.01 vs control). The fasting glucose levels decreased by 0.21±0.20 mmol/L in Group 1 and by 0.48±0.25 mmol/L in Group 2 (&lt;0.01 vs control, both), but there were no meaningful improvements in blood lipids or CRP. Long-term (6 months) secondary prevention programs incorporating remote support technologies result into sustained improvement of key secondary prevention indicators in obese CHD patients, irrespective of the support modality (by phone or via electronic messaging).

P2512Effects of two different preventive counselling programs with remote support on added sugar and refined carbohydrates intake pattern in coronary patients with abdominal obesity

Abstract Background Restricting added sugar and refined carbohydrates is essential for a healthy diet, especially for overweight or obese patients (pts). Pts education has a potential to improve dietary patterns in coronary artery disease (CHD). Purpose To assess the impact of 2 preventive counselling programs with subsequent remote support resulted after hospitalization on salt intake in pts with CHD and obesity. Methods A prospective randomized parallel-group study in hospitalized nonsurgical pts with confirmed stable CHD and concomitant abdominal obesity. Most hospitalizations were due to elective percutaneous coronary intervention. Pts were randomized (1:1:1) into 3 groups. Before discharge, Groups 1 and 2 received comprehensive counselling with focus on diet followed by remote counselling by phone (Group 1) or via text messages (Group 2). Remote counselling was delivered weekly (Months 1–3) and then monthly (Months 4–6). Group 3 received standard advice only. Self-reported sugar/refined carbohydrates intake was assessed by consumption of added sugar, sugar-sweetened beverages and pastry. Results A total of 120 pts (mean age±SD, 57.75±6.25 years, men, 83.4%) were enrolled. The table presents self-reported dietary habits at baseline and at 12 months. At 1 year, significant improvements of relevant dietary habits vs control were seen in both intervention groups. Group 1 Group 2 Group 3 (control) Group 1 vs 3, Group 2 vs 3, (n=40) (n=40) (n=40) P for change from baseline P for change from baseline Amount of sugar added per cup tea or coffee, teaspoons, mean ± SD Baseline 2.65±0.77 2.45±0.81 2.48±0.72 At 12 months 2.08±0.83** 1.95±0.64** 2.47±0.69 &lt;0.01 &lt;0.01 Pts avoiding sugar-sweetened beverages, % Baseline 37.50 32.50 25.00 At 12 months 92.50** 90.00** 13.16 &lt;0.01 &lt;0.01 Pts restricting pastry to no more than 1–2 times a week, % Baseline 37.5% 47.5% 57.5 At 12 months 70.0%** 72.5%** 39.47 &lt;0.01 &lt;0.05 **p&lt;0.01 vs baseline within group. Conclusion Pre-discharge preventive counselling with subsequent remote support in coronary patients with abdominal obesity resulted in significant improvement of dietary habits in terms of added sugar, sugar-sweetened beverages and pastry intake.

P2511Effects of two different preventive counselling programs with remote support on salt and sodium-reach foods intake patterns in coronary patients with abdominal obesity

Abstract Background Salt restriction is essential for a healthy diet, especially for patients (pts) with cardiovascular diseases. Pts education has a potential to promote healthier dietary patterns. Purpose To assess the impact of 2 preventive counselling programs with subsequent remote support resulted after hospitalization on salt intake in pts with coronary artery disease (CHD). Methods A prospective randomized parallel-group study in hospitalized nonsurgical pts with confirmed stable CHD and concomitant abdominal obesity. Most hospitalizations were due to elective percutaneous coronary intervention. Pts were randomized (1:1:1) into 3 groups. Before discharge, Groups 1 and 2 received comprehensive counselling with focus on diet followed by remote counselling by phone (Group 1) or via text messages (Group 2). Remote counselling was delivered weekly (Months 1–3) and then monthly (Months 4–6). Group 3 received standard advice only. Self-reported salt intake was assessed by consumption of sodium-reach foods such as sausages, pickles and by adding salt to cooked foods. Results A total of 120 pts (mean age±SD, 57,75±6,25 years, men, 83.4%) were enrolled. The Table presents self-reported dietary habits at baseline and at 12 months. At 1 year, significant improvements of relevant dietary habits vs control were seen in both intervention groups. Group 1 Group 2 Group 3 (Control) Group 1 vs 3, Group 2 vs 3, (n=40) (n=40) (n=40) P for change from baseline P for change from baseline Pts adding salt to cooked foods at least sometimes Baseline 87.5% 90.0% 85.0% At 12 months 25.0%** 10.0%** 89.5% &lt;0.01 &lt;0.01 Pts avoiding pickled vegetables Baseline 17.5% 20.0% 15.4% At 12 months 62.5%* 77.5%** 7.9% &lt;0.05 &lt;0.01 Pts avoiding wurst, sausages, smoked meats Baseline 0.0% 10.0% 7.5% At 12 months 77.5%** 87.5%** 2.6% &lt;0.01 &lt;0.01 *p&lt;0.05, **p&lt;0.01 vs baseline within group. Conclusion Pre-discharge preventive counselling with subsequent remote support in coronary patients with abdominal obesity resulted in significant improvement of dietary habits in terms of salt and high-sodium foods intake.

Reducing the Risk of Developing Diabetes.

Reducing the Risk of Developing Diabetes.

Does combined general–epidural anesthesia reduce the risk for surgical site infections in radical cystectomy?

Background Radical cystectomy is an aggressive surgical procedure associated with the highest morbidity and mortality of all commonly performed urological procedures. It has been assumed that regional anesthesia may reduce infectious complications. Objective This aim of this study was to compare whether general anesthesia (GA) combined with epidural anesthesia reduces the incidence of superficial and deep surgical site infections, chest infection, mortality rate, and length of hospital stay. Patients and methods In this prospective randomized parallel group study, 150 patients between 50 and 65 years of age who were scheduled for elective radical cystectomy were randomly divided into two groups: the GA-only group (n=75), which received GA-alone, and the Epi–GA group (n=75), which received both GA and epidural anesthesia. Demographic and clinical data, such as age, sex, and BMI, and surgical data, such as duration of surgical procedure and number of whole blood units given, were recorded. Postoperative data such as superficial and deep surgical site infections, chest infection diagnosed by the consultant over 10 days’ duration, mortality rate, and duration of hospital stay were recorded. Results Demographic, clinical, and surgical data were similar among the study groups. There was no significant difference between the study groups as regards the incidence of superficial and deep surgical site infections, chest infection, and mortality rate. The duration of hospital stay was significantly shorter in the Epi–GA group compared with the GA-only group. Conclusion Our study showed that combined GA and epidural anesthesia offers no advantage over GA alone with regard to the incidence of infectious complications within 10 days postoperatively, but it significantly reduced the length of hospital stay.

Efficacy of concurrent administration of mifepristone and misoprostol for termination of pregnancy

In this prospective randomized parallel group study, subjects with a pregnancy of less than 63 d were randomized to receive either (i) 200 mg oral mifepristone plus 400 μg misoprostol per vaginally concurrently (group A); (ii) or the administration of misoprostol after 48 h (group B). Transvaginal sonography was performed on the 14th day of misoprostol administration to confirm complete abortion. The primary outcome was to compare the rates of complete abortion in two groups. Secondary outcomes were to compare induction abortion interval, side effects and compliance. A total of 200 subjects included in the study were randomized into groups A and B (100 each). Both the groups were comparable for age, parity, gestational age and history of previous abortion. The complete expulsion rate in group A was 96% (95% confidence interval (CI) 95.1–98.2%) and group B was 95% (95% CI 93.0–96.8%) (p > 0.100). A gestational age of more than 56 d was found to predict failure of treatment in both groups. The adverse effect profile in the two groups was the same. Efficacy of concurrent mifepristone and misoprostol in combination is similar to that when misoprostol is given 48 h later (ctri.nic.in CTRI/2010/091/001422).

Randomized controlled study comparing the hemodynamic response to laryngoscopy and endotracheal intubation with McCoy, Macintosh, and C-MAC laryngoscopes in adult patients.

Background and Aims:Earlier studies have shown that the type of laryngoscope blade influences the degree of hemodynamic response to endotracheal intubation. The aim of the study was to evaluate the hemodynamic response to oral endotracheal intubation with C-MAC laryngoscopy and McCoy laryngoscopy compared to that of Macintosh laryngoscopy in adult patients under general anesthesia.Material and Methods:This is a prospective randomized parallel group study. Ninety American Society of Anesthesiologists I patients were randomly allotted into three groups. Group A – Macintosh laryngoscopy (control group). Group B – laryngoscopy with McCoy laryngoscope. Group C – laryngoscopy with C-MAC video laryngoscope. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were monitored at baseline (just before induction), just before intubation (T0), 1 min (T1), 3 min (T3), 5 min (T5), and 10 min (T10) after intubation. Intergroup comparison of study parameters was done by unpaired sample t-test for normal data and Mann-Whitney U-test for skewed data. For within-group comparison, the repeated measures of ANOVA for normal data and Friedman followed by Wilcoxon signed rank test for skewed data were performed.Results:In C-MAC group, the HR was significantly higher than the Macintosh group at 3 min after intubation, whereas SBP, DBP, and MAP were significantly higher at 1 min. McCoy group showed a similar response compared to Macintosh group at all time intervals.Conclusion:C-MAC video laryngoscope has a comparatively greater hemodynamic response than Macintosh laryngoscope.

Comparison of post operative analgesia with Fentanyl and Sulfentanil via epidural route in thoracic and upper abdominal surgeries

Background: Post-operative analgesia has been considered very important for patient in terms of early mobilization and prevention of complications. Opioid analgesics have long been recognized as among the most effective treatments for pain. Opioids like fentanyl and sufentanil have been successfully used for post-operative analgesia by epidural route. Aims & Objective: To evaluate the efficacy of Sufentanil and Fentanyl for post-operative analgesia following thoracic and upper abdominal surgeries through epidural route. Materials and Methods: This was a prospective randomized parallel group study of 60 patients. They were divided into two groups randomly, F and SF. They were given fentanyl and sufentanil by epidural route for post-operative pain relief following upper abdominal and Thoracic surgery. Pain was assessed through Visual analogue scale. Pain Relief assessment, Pulse rate, BP, Respiratory rate, SPO2, Sedation Score and complication if any were assessed after administration of drug at 0,2,5,10,30,60,,120, 240 and 300 minutes. Result obtained were statistically analysed using students unpaired t test after calculating mean and standard deviation. Results: Patients in both group were comparable in terms of demography with male predominance, ASA grade and type of surgery performed. Onset of pain relief was 7.22 ± 1.82 minutes with fentanyl while 3.40±0.90 with sufentanil. Peak analgesic effect was achieved at 20.36 ± 3.44 minutes with fentanyl while it was quicker with sufentanil (9.3±2.4). Duration of analgesia was higher in sufentanil group (254.1 ± 53.80) in comparison to fentanyl (185.2 ± 43.33). Conclusion: Sufentanil via epidural route provides early onset, peak effect and longer duration of effective analgesia in comparison to Fentanyl. Use of either drug via epidural route provide safety and better stabilization as far as the hemodynamic and respiratory parameters were concerned. But, Patients with sufentanil remained sedated for longer duration than fentanyl.

Intraoperative blood glucose levels in nondiabetic patients undergoing elective major surgery under general anaesthesia receiving different crystalloid solutions for maintenance fluid.

Context:The study was undertaken to observe the effect of different maintenance-fluid regimen on intraoperative blood glucose levels in non-diabetic patients undergoing elective major non-cardiac surgery under general anesthesia.Aims:To know the intraoperative blood glucose levels.Settings and Design:Prospective randomized parallel group study.Subjects and Methods:Two hundred non-diabetic patients (100 in each group) aged between 18 years and 60 years were enrolled for this prospective randomized parallel group study. Group A patients received Ringer's lactate solution and Group B patients received 0.45% sodium chloride with 5% dextrose and 20 mmol/L potassium chloride as maintenance fluid. Capillary blood glucose (CBG) level was measured immediately before initiation of intravenous fluid therapy and thereafter hourly till the end of surgery. If at any time intraoperative CBG was found to be more than or equal to 150 mg/dL calculated dose of human soluble insulin was given as intravenous bolus equal to the amount of CBG/100 units.Statistical Analysis Used:For comparison of normally distributed variables independent sample t test was done. For rest of the data, i.e., CBG_0, CBG_4 and insulin consumption Mann-Whitney U test was employed.Results:63% patients in group B developed at least one episode of hyperglycemia CBG ≥ 150 mg/dL) but only 29% in the Group A did so. Insulin consumption was significantly higher in Group B than in Group A to maintain normoglycemia. The relative risk of becoming hyperglycemic in Group B patients is 2.172 (95% CI 1.544 to 3.057). Number needed to harm, i.e., hyperglycemia, in Group B is 2.941 (95% CI 2 to 5).Conclusions:We conclude that stress induced-hyperglycemic response in patients undergoing major non-cardiac surgery is common in non-diabetic population. Maintenance-fluid therapy by dextrose containing solution as opposed to Ringer's lactate solution increases the incidence of hyperglycemia. To achieve normoglycemia by intravenous bolus dose of human regular insulin, significantly higher doses are required in patients receiving dextrose containing saline as maintenance fluid.

Comparative evaluation of four therapeutic regimes in chikungunya arthritis: a prospective randomized parallel-group study

Objective To evolve a treatment protocol for patients presenting in acute stage of chikungunya by identifying the best regimen from four treatment regimes. Materials and methods One hundred and twenty patients diagnosed to have chikungunya arthritis clinically were randomized to one of four groups receiving combinations of aceclofenac (200 mg/day), hydroxychloroquine (400 mg/day) and prednisolone (10 mg/day). Group A received aceclofenac alone; Group B received aceclofenac plus hydroxychloroquine; Group C received aceclofenac and prednisolone and Group D, all three agents. Study medications were given for 6 weeks with weekly follow-ups followed by a 6 weeks drug-free follow-up with visits at week 8 and week 12. Efficacy variables including visual analog scale (VAS) for pain, 20-point modified Barthel index for activities of daily living (ADL) and instrumental activities of daily living (IADL) were assessed and recorded during start of therapy and at all follow-up visits. Results Significant ( P < 0.001) reduction in VAS scores and improvement in ADL and IADL scores were observed in groups C and D compared to groups A and B. Between groups A and B there was no significant difference; similarly, between groups C and D also there was no significant difference. Conclusion Addition of prednisolone, and not hydroxychloroquine, to aceclofenac reduced pain and improved the quality of life in patients with acute chikungunya arthritis, compared to aceclofenac given alone in the management of early chikungunya fever. We propose a combination of non-steroidal anti-inflammatory drugs with corticosteroid as the best regimen in treating acute chikungunya cases with arthralgia.

The Hannover Dialysis Outcome study: comparison of standard versus intensified extended dialysis for treatment of patients with acute kidney injury in the intensive care unit

Increasing the dose of renal replacement therapy has been shown to improve survival in critically ill patients with acute kidney injury (AKI) in several smaller European trials. However, a very recent large multicentre trial in the USA could not detect an effect of dose of renal replacement therapy on mortality. Based on those studies, it is not known whether a further increase in dialysis dose above and beyond the currently employed doses would improve survival in patients with AKI. We therefore aimed to assess mortality and renal recovery of patients with AKI receiving either standard (SED) or intensified extended dialysis (IED) therapy in the intensive care unit. A prospective randomized parallel group study was conducted in seven intensive care units of a tertiary university hospital. Pre-existing chronic kidney disease was an exclusion criterion. A total of 156 patients (570 screened) with AKI requiring renal replacement therapy were randomly assigned to receive standard dialysis [dosed to maintain plasma urea levels between 120 and 150 mg/dL (20-25 mmol/L)] or intensified dialysis [dosed to maintain plasma urea levels <90 mg/dL (<15 mmol/L)]. Outcome measures were survival at Day 14 (primary) and survival and renal recovery at Day 28 (secondary) after initiation of renal replacement therapy. Treatment intensity differed significantly (P < 0.01 for plasma urea and administered dose). No differences between intensified and standard treatment were seen for survival by Day 14 (70.4% versus 70.7%) or Day 28 (55.6% versus 61.3%), or for renal recovery amongst the survivors by Day 28 (60.0% versus 63.0%). Although this study cannot deliver a definitive answer, it suggests that increasing the dose of extended dialysis above the currently recommended dose might neither reduce mortality nor improve renal recovery in critically ill patients, mainly septic patients, with AKI.

A randomized prospective trial comparing single dose prostaglandin E2 vaginal gel with forewater amniotomy for induction of labour

A prospective randomized parallel-group study was carried out to compare the efficacy of a single dose vaginal prostaglandin E2 gel with forewater amniotomy for induction of labour at term in 260 parturients (110 primigravid and 150 parous women) with low risk pregnancy and favourable cervix. In the prostaglandin E2 (PGE2) managed group, the primigravidae were treated with 2 mg PGE2 gel and parous patients with 1 mg PGE2 gel. Forewater amniotomy was performed 4 h later, or sooner if women requested analgesia. In the amniotomy group, artificial forewater amniotomy was carried out and a repeat cervical assessment done 4 h later, or sooner if women requested analgesia. In both groups, intravenous oxytocin was established if there was evidence of disordered uterine activity, 6 h after the start of initial intervention. An assessment of consumers' views was carried out by using a standardized questionnaire completed 48 h after delivery. There was a significant reduction in the requirement for oxytocin augmentation in women treated with PGE2: primigravidae, odds ratio (OR), 0.27 and 95% confidence interval (CI), 0.12-0.61; multiparae, OR, 0.19 and 95% CI, 0.08-0.45. Fewer primigravidae managed with PGE2 gel required epidural analgesia (OR, 0.16; 95% CI, 0.06-1.00). Fewer parous women managed with PGE2 gel required parenteral opiates (OR, 0.44; 95% CI, 0.23-0.85) and more women required inhalation analgesia or no analgesia (OR, 2.22; 95% CI, 1.76-2.79). The intervention to delivery intervals were shortened in PGE2 groups independent of parity but the differences were not significant.(ABSTRACT TRUNCATED AT 250 WORDS)