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NCT Number: NCT02718261

Sup-Icu RENal (SIREN)

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.

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Key information

Conditions

Critical Illness Acute Kidney Injury Chronic Disease Disease Attributes End-stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proton Pump Inhibitor Renal Insufficiency Renal Insufficiency, Chronic Renal Replacement Therapy Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rigshospitalet, Copenhagen, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • please refer to SUP-ICU (NCT02467621) trial

Exclusion criteria

  • please refer to SUP-ICU (NCT02467621) trial

Treatment and study plan

Pantoprazole

Drug

Saline 0.9% (matching placebo)

Drug

Primary outcomes

  1. The proportion of patients with clinically important GI bleeding

    Time frame: 90 days or length of ICU stay, as applicable

Secondary outcomes

  1. 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

    Time frame: 90 days or length of ICU stay, as applicable

  2. Proportion of patients with serious adverse reactions

    Time frame: 90 days or length of ICU stay, as applicable

  3. Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU

    Time frame: 90 days or length of ICU stay, as applicable

  4. Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period

    Time frame: 90 days or length of ICU stay, as applicable

  5. 90-day and 1-year (365 days) mortality post-randomization

    Time frame: 90 days/365 days or length of ICU stay, as applicable

  6. Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).

    Time frame: 90 days or length of ICU stay, as applicable

  7. Number of units of packed red blood cells (RBCs) transfused.

    Time frame: 90 days or length of ICU stay, as applicable

  8. 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.

    Time frame: 90 day, 360 days, or length of ICU stay, as applicable

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study 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

Acronym: SIREN

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 24, 2016
Registry last updated
Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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