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Sup-Icu RENal (SIREN)

NCT02718261 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 3350

Last updated 2018-09-11

No results posted yet for this study

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

DRUG

Pantoprazole

DRUG

Saline 0.9% (matching placebo)

Sponsors & Collaborators

  • Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)

    collaborator UNKNOWN

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Denmark
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02718261 on ClinicalTrials.gov