Trial Files Throwback Thursday: Dialysis in ICU Patients, Bariatric Surgery Referral, and IV PPI for Bleeding Ulcers
Why don’t we prescribe high-intensity dialysis for critically ill patients with acute renal failure?
Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients (RENAL)
The RENAL Replacement Therapy Study Investigators. NEJM (October 2009)
Bottom line: This multicenter, randomized trial compared the effect of two different levels of intensity of continuous renal-replacement therapy (RRT) on 90-day mortality in critically ill patients with acute kidney injury. The study included 1508 patients who were randomly assigned to receive RRT in the form of postdilution continuous venovenous hemodiafiltration with an effluent flow of either 40 mL/kg per hour (higher intensity, n = 747) or 25 mL/kg per hour (lower intensity, n = 761). Both groups had similar baseline characteristics and received the study treatment for an average of 6.3 and 5.9 days, respectively (P=0.35). At 90 days, there was no statistically significant difference in the primary outcome of mortality at 90 days after randomization between the two groups. At 90 days, 6.8% of survivors in the higher-intensity group (27 of 399), as compared with 4.4% of survivors in the lower-intensity group (18 of 411), were still receiving renal-replacement therapy (odds ratio, 1.59; 95% CI, 0.86 to 2.92; P=0.14). However, hypophosphatemia was more common in the higher-intensity group. Overall, the study concluded that higher-intensity continuous renal-replacement therapy did not reduce mortality in this patient population.
Why should I consider referral for bariatric surgery in patients with severe obesity?
Effects of Bariatric Surgery on Mortality in Swedish Obese Subjects (SOS)
Sjöström L et al. NEJM (August 2007)
Bottom Line: This prospective, controlled study involved 4047 patients ages 37-60 years old with severe obesity (BMI ≥ 34 for men or ≥ 38 for women) who were randomized to undergo either bariatric surgery (surgery group, n = 2020) or conventional treatment (control group, n = 2037). The average weight change in control subjects was less than ±2% during the period of up to 15 years during which weights were recorded. Maximum weight losses in the surgical subgroups were observed after 1 to 2 years: gastric bypass, 32%; vertical-banded gastroplasty, 25%; and banding, 20%. After 10 years, the weight losses from baseline were stabilized at 25%, 16%, and 14%, respectively. The primary outcome was overall mortality at an average of 10.9 years of follow-up, with 101 deaths in the surgery group and 129 deaths in the control group. The adjusted hazard ratio for overall mortality was 0.71 in the surgery group, indicating a decreased risk compared to the control group (P = 0.01). The most common causes of death were myocardial infarction and cancer. Bariatric surgery for severe obesity was found to be associated with long-term weight loss and decreased overall mortality.
What’s the evidence for short-term IV PPI to prevent recurrent bleeds after endoscopic treatment of bleeding peptic ulcers?
Effect of Intravenous Omeprazole on Recurrent Bleeding after Endoscopic Treatment of Bleeding Peptic Ulcers
Lau J et al. NEJM (August 2000)
Bottom Line: This randomized, double-blind clinical trial assessed the effectiveness of a high-dose infusion of omeprazole in reducing the risk of recurrent bleeding after endoscopic treatment of bleeding peptic ulcers. The study included 240 patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels who were treated with epinephrine injection followed by thermocoagulation. After hemostasis had been achieved, they were randomly assigned to receive omeprazole (bolus IV injection of 80 mg followed by 8 mg/hour infusion for 72 hours) or placebo. After the infusion, all patients were given 20 mg of omeprazole orally per day for eight weeks. The primary outcome was recurrent bleeding within 30 days after endoscopy, and the results showed a significant reduction in the omeprazole group compared to placebo (6.7% vs 22.5%; hazard ratio, 3.9; 95 percent confidence interval, 1.7 to 9.0). Most episodes of recurrent bleeding occurred within the first three days during the infusion period (5 in the omeprazole group and 24 in the placebo group, P<0.001). Safety outcomes showed a lower mortality rate in the omeprazole group (4.2% vs 10%, P = 0.13). In conclusion, high-dose infusion of omeprazole was found to be effective in reducing the risk of recurrent bleeding in this patient population.
Trial Files Issue #2024-21
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