NCT02718261

Sup-Icu RENal (SIREN)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3,350 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness
• Acute Kidney Injury
• End-stage Renal Disease
• Renal Replacement Therapy
• Proton Pump Inhibitor

Interventions

Type	Name	Description
DRUG	Pantoprazole
DRUG	Saline 0.9% (matching placebo)

Timeline

• Start date: 2016-02-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-03-24
• Last updated: 2018-09-11

Locations

2 sites across 2 countries: Denmark, Switzerland