Sup-Icu RENal (SIREN)

Phase 4

Completed

• Conditions: Proton Pump Inhibitor; End-stage Renal Disease; Critical Illness; Renal Replacement Therapy; Acute Kidney Injury
• Interventions: Drug: Pantoprazole; Drug: Saline 0.9% (matching placebo)

• Registration Number: NCT02718261
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-22
• Study First Posted: 2016-03-24
• Status Verified: 2018-09
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3350

Inclusion Criteria

• please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria

• please refer to SUP-ICU (NCT02467621) trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum (pantoprazole)	Pantoprazole	-
Placebo	Saline 0.9% (matching placebo)	0.9% saline

Primary Outcome Measures

Name	Time	Method
The proportion of patients with clinically important GI bleeding	90 days or length of ICU stay, as applicable

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with serious adverse reactions	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
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
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 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

Trial Locations

Locations (2)

Dept. of Intensive Care Medicine, University of Bern,; 🇨🇭 Bern, Switzerland

Rigshospitalet; 🇩🇰 Copenhagen, Denmark