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Sup-Icu RENal (SIREN) (SIREN)

Primary Purpose

Critical Illness, Acute Kidney Injury, End-stage Renal Disease

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Pantoprazole

Saline 0.9% (matching placebo)

About this trial

This is an interventional other trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

please refer to SUP-ICU (NCT02467621) trial

Sites / Locations

Rigshospitalet
Dept. of Intensive Care Medicine, University of Bern,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Verum (pantoprazole)

Placebo

Arm Description

0.9% saline

Outcomes

Primary Outcome Measures

The proportion of patients with clinically important GI bleeding

Secondary Outcome Measures

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

Proportion of patients with serious adverse reactions

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

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

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

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

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

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.

Full Information

NCT ID

NCT02718261

First Posted

March 14, 2016

Last Updated

September 10, 2018

Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02718261

Brief Title

Sup-Icu RENal (SIREN)

Acronym

SIREN

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Completed

Study Start Date

February 2016 (Actual)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Insel Gruppe AG, University Hospital Bern

Collaborators

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

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

3350 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Verum (pantoprazole)

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0.9% saline

Intervention Type

Drug

Intervention Name(s)

Pantoprazole

Intervention Type

Drug

Intervention Name(s)

Saline 0.9% (matching placebo)

Primary Outcome Measure Information:

Title

The proportion of patients with clinically important GI bleeding

Time Frame

90 days or length of ICU stay, as applicable

Secondary Outcome Measure Information:

Title

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

Title

Proportion of patients with serious adverse reactions

Time Frame

90 days or length of ICU stay, as applicable

Title

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

Title

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

Title

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

Time Frame

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

Title

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

Title

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

Time Frame

90 days or length of ICU stay, as applicable

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: please refer to SUP-ICU (NCT02467621) trial Exclusion Criteria: please refer to SUP-ICU (NCT02467621) trial

Facility Information:

Facility Name

Rigshospitalet

City

Copenhagen

Country

Denmark

Facility Name

Dept. of Intensive Care Medicine, University of Bern,

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

31480045

Citation

Schefold JC, Krag M, Marker S, Perner A, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Lange T, Moller MH; the SUP-ICU investigators. Outcomes of Prophylactic Pantoprazole in Adult Intensive Care Unit Patients Receiving Dialysis: Results of a Randomized Trial. Am J Nephrol. 2019;50(4):312-319. doi: 10.1159/000502732. Epub 2019 Sep 3.

Results Reference

derived

PubMed Identifier

29321041

Citation

Schefold JC, Perner A, Lange T, Wetterslev J, Wise MP, Borthwick M, Bendel S, Keus F, Guttormsen AB, Marker S, Krag M, Moller MH; SUP-ICU investigators. Effects of stress ulcer prophylaxis in adult ICU patients receiving renal replacement therapy (Sup-Icu RENal, SIREN): Study protocol for a pre-planned observational study. Trials. 2018 Jan 10;19(1):26. doi: 10.1186/s13063-017-2408-3.

Results Reference

derived

Links:

URL

http://www.sup-icu.com

Description

Homepage SUP-ICU RCT

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://clinicaltrials.gov/ct2/show/NCT02467621?term=SUP-ICU&rank=1

Available IPD/Information Identifier

NCT02467621

Available IPD/Information Comments

SUP-ICU Website

Learn more about this trial

Sup-Icu RENal (SIREN)

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