Sup-Icu RENal (SIREN)

Insel Gruppe AG, University Hospital Bern

Status and phase: Completed; Phase 4

Conditions: Proton Pump Inhibitor; Renal Replacement Therapy; Acute Kidney Injury; Critical Illness; End-stage Renal Disease

Treatments: Drug: Pantoprazole; Drug: Saline 0.9% (matching placebo)

Study type: Interventional

Funder types: Other

Identifiers

NCT02718261

SIREN

Details and patient eligibility

About

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.

Enrollment: 3,350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• please refer to SUP-ICU (NCT02467621) trial

Exclusion criteria

• please refer to SUP-ICU (NCT02467621) trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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3,350 participants in 2 patient groups, including a placebo group

Verum (pantoprazole)

Experimental group

Treatment:

Drug: Pantoprazole

Placebo

Placebo Comparator group

Description:

0.9% saline

Treatment:

Drug: Saline 0.9% (matching placebo)