Trial Files Throwback: When should dialysis be started in ESRD?, Bariatric Surgery cures Diabetes, and Prone Positioning in Severe ARDS

Aug 25, 2025

Join us on September 4th, 2025, from 12-1 pm for a free crash course on anemia and thrombocytopenia.

Speaker details: Dr. Mike Fralick is a Clinician Scientist who works in Toronto and Sault Ste. Marie.

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Early dialysis is not better than late dialysis!

A randomized, controlled trial of early versus late initiation of dialysis (IDEAL)

Cooper BA et al. NEJM (August 2010)

Bottom Line: This randomized clinical trial evaluated the impact of early versus late initiation of dialysis on survival in adults with stage V chronic kidney disease across 32 centers in Australia and New Zealand. A total of 828 participants were assigned to either early initiation (GFR 10.0 to 14.0 ml/min) or late initiation (GFR 5.0 to 7.0 ml/min (mean age, 60.4 years; 542 men and 286 women; 355 with diabetes). The primary outcome was death from any cause over a median follow-up of 3.59 years, with 37.6% mortality in the early-start group and 36.6% in the late-start group (hazard ratio 1.04, 95% CI 0.83 to 1.30, P=0.75). There were no significant differences in adverse events between groups, leading to the conclusion that early dialysis initiation did not improve survival or clinical outcomes.

LINK TO ARTICLE (IDEAL)


Bariatric surgery can cure diabetes in adults with diabetes and obesity!

Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 5-Year Outcomes (STAMPEDE)

Schauer PR et al. NEJM (February 2017)

Bottom line: This randomized controlled trial assessed the long-term outcomes of intensive medical therapy alone versus intensive medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 patients with type 2 diabetes and a BMI of 27 to 43 over 5 years. The primary outcome was glycated hemoglobin level of 6.0% or less, evaluated at 5 years. Results showed 29% of gastric bypass patients and 23% of sleeve gastrectomy patients met the primary outcome compared to 5% in the medical therapy group. Safety outcomes indicated no major late surgical complications except for one reoperation. The study concluded that bariatric surgery combined with intensive medical therapy was more effective in reducing hyperglycemia compared to medical therapy alone.

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LINK TO ARTICLE (STAMPEDE)


What patients with ARDS should be proned?

Prone positioning in severe acute respiratory distress syndrome (PROSEVA)

Guérin C et al. NEJM (May 2013)

Bottom Line: This multicenter, prospective, randomized, controlled trial evaluated the effect of early prone positioning on outcomes in patients with severe ARDS over a duration of 28 days. A total of 466 patients were randomly assigned to either prone-positioning sessions of at least 16 hours or to the supine position. The primary outcome was the proportion of patients who died from any cause within 28 days, with results showing 16.0% mortality in the prone group compared to 32.8% in the supine group (P<0.001). The study found that prone positioning significantly reduced mortality rates, while the incidence of complications was similar, except for higher cardiac arrests in the supine group.

LINK TO ARTICLE (PROSEVA)


Trial Files Issue #2025-18