Data show that episodes of bleeding may often be observed in critically ill patients with dialysis-dependent acute renal failure (ARF) on renal replacement therapy (RRT). From a clinical perspective, patients with dialysis-dependent ARF and end-stage renal disease (ESRD) may be considered a high risk population in regard to e.g. development of gastrointestinal (GI-) bleeding. In the current prospective subanalysis "SIREN" of the randomized placebo-controlled clinical trial "SUP-ICU" (NCT02467621), the investigators seek to elucidate whether the subpopulation of critically ill patients with acute kidney injury requiring renal replacement therapy (RRT) benefit from prophylactic treatment with a proton-pump-inhibitor such as pantoprazole.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
3,350
Rigshospitalet
Copenhagen, Denmark
Dept. of Intensive Care Medicine, University of Bern,
Bern, Switzerland
The proportion of patients with clinically important GI bleeding
Time frame: 90 days or length of ICU stay, as applicable
Proportion of patients with one or more of the following adverse events: clinically important GI bleeding, pneumonia, C. difficile infection, or acute myocardial ischemia in the ICU
Time frame: 90 days or length of ICU stay, as applicable
Proportion of patients with serious adverse reactions
Time frame: 90 days or length of ICU stay, as applicable
Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU
Time frame: 90 days or length of ICU stay, as applicable
Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period
Time frame: 90 days or length of ICU stay, as applicable
90-day and 1-year (365 days) mortality post-randomization
Time frame: 90 days/365 days or length of ICU stay, as applicable
Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).
Time frame: 90 days or length of ICU stay, as applicable
Number of units of packed red blood cells (RBCs) transfused.
Time frame: 90 days or length of ICU stay, as applicable
90-day/360-day/ ICU mortality rate in "RRT group" vs. "ESRD group" vs. "RRT at any time on the ICU" vs. "control group" incl. analysis of verum/ placebo subgroups.
Time frame: 90 day, 360 days, or length of ICU stay, as applicable
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