Effects of Pantoprazole Based on Dialysis Status: A Protocol and Statistical Analysis Plan for a Secondary Analysis of the REVISE Trial

In the REVISE Trial secondary analysis, kidney failure requiring any RRT on study day 1 will be tested for modifying pantoprazole’s effect on upper GI bleeding and 90-day mortality.

• Why it matters: Renal insufficiency may raise bleeding risk and PPI use may be linked to adverse kidney outcomes, so it is clinically important to know whether RRT status changes pantoprazole benefit.
• What they did: A post hoc analysis of the REVISE Trial (NCT03374800) will use Cox proportional-hazard models with RRT exposure, randomized group, and their interaction, reporting hazard ratios, 95% confidence intervals, and interaction p-values.
• The result: Findings will clarify whether RRT at baseline—especially maintenance outpatient RRT—alters pantoprazole effects on clinically important upper GI bleeding and 90-day mortality, informing ICU practice.

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