A Phase 4 interventional study of Pantoprazole and Saline 0.9% (matching placebo) in Critical Illness, Acute Kidney Injury and End-stage Renal Disease, sponsored by Insel Gruppe AG, University Hospital Bern. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-11.
Sponsored by Insel Gruppe AG, University Hospital Bern · Phase 4, Interventional, and Other
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 3,350 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Pantoprazole
0.9% saline
Drug: Saline 0.9% (matching placebo)
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
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Insel Gruppe AG, University Hospital Bern