Clinical trial NCT02718261: Sup-Icu RENal (SIREN)
Official title: Sup-Icu RENal (SIREN) - a Sub-analysis of the Prospective SUP (Stress Ulcer Prophylaxis)-ICU Trial on the Risk of GI- Bleeding in ICU Patients Receiving Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Acute Kidney Injury
End-stage Renal Disease
Renal Replacement Therapy
Proton Pump Inhibitor
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)
First posted: 2016-03-24
Enrollment: 3350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

* please refer to SUP-ICU (NCT02467621) trial

Primary outcomes:
measure: The proportion of patients with clinically important GI bleeding
timeFrame: 90 days or length of ICU stay, as applicable
Secondary outcomes:
measure: 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
timeFrame: 90 days or length of ICU stay, as applicable
measure: Proportion of patients with serious adverse reactions
timeFrame: 90 days or length of ICU stay, as applicable
measure: Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU
timeFrame: 90 days or length of ICU stay, as applicable
measure: Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period
timeFrame: 90 days or length of ICU stay, as applicable
measure: 90-day and 1-year (365 days) mortality post-randomization
timeFrame: 90 days/365 days or length of ICU stay, as applicable
measure: Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).
timeFrame: 90 days or length of ICU stay, as applicable
measure: Number of units of packed red blood cells (RBCs) transfused.
timeFrame: 90 days or length of ICU stay, as applicable
measure: 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.
timeFrame: 90 day, 360 days, or length of ICU stay, as applicable
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bern
country: Switzerland
facility: Dept. of Intensive Care Medicine, University of Bern,
Study officials:
References:
citation: Schefold JC, Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Lange T, Moller MH; the SUP-ICU investigators. Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial. Am J Nephrol. 2019;50(4):312-319. doi: 10.1159/000502732. Epub 2019 Sep 3.
citation: Schefold JC, Perner A, Lange T, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Marker S, Krag M, Moller MH; SUP-ICU investigators. Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study. Trials. 2018 Jan 10;19(1):26. doi: 10.1186/s13063-017-2408-3.