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

Background A recent international randomized trial found that the proton pump inhibitor (PPI) pantoprazole significantly reduced the risk of clinically important upper gastrointestinal (GI) bleeding among invasively ventilated patients in the intensive care unit (ICU), with no effect on mortality. Pantoprazole may be of particularly high utility among patients at high-risk of bleeding, such as those receiving renal replacement therapy (RRT) prior to ICU admission. However, given the complex mechanisms by which renal insufficiency may increase bleeding risk, as well as the possible association

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