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Clinical Trial Details

Trial ID: L1550
Source ID: NCT02718261
Associated Drug: Pantoprazole
Title: Sup-Icu RENal (SIREN)
Acronym: SIREN
Status: COMPLETED
Study Results: NO
Results:
Conditions: Critical Illness|Acute Kidney Injury|End-stage Renal Disease|Renal Replacement Therapy|Proton Pump Inhibitor
Interventions: DRUG: Pantoprazole|DRUG: Saline 0.9% (matching placebo)
Outcome Measures: Primary: The proportion of patients with clinically important GI bleeding, 90 days or length of ICU stay, as applicable | Secondary: 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, 90 days or length of ICU stay, as applicable|Proportion of patients with serious adverse reactions, 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, 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, 90 days or length of ICU stay, as applicable|90-day and 1-year (365 days) mortality post-randomization, 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)., 90 days or length of ICU stay, as applicable|Number of units of packed red blood cells (RBCs) transfused., 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., 90 day, 360 days, or length of ICU stay, as applicable
Sponsor/Collaborators: Sponsor: Insel Gruppe AG, University Hospital Bern | Collaborators: Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 3350
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2016-02
Completion Date: 2018-09
Results First Posted:
Last Update Posted: 2018-09-11
Locations: Rigshospitalet, Copenhagen, Denmark|Dept. of Intensive Care Medicine, University of Bern,, Bern, 3010, Switzerland
URL: https://clinicaltrials.gov/show/NCT02718261