Sup-Icu RENal (SIREN)

Critical Illness Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02718261
• Other study ID #: SIREN
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3350
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• please refer to SUP-ICU (NCT02467621) trial

Exclusion Criteria:

• please refer to SUP-ICU (NCT02467621) trial

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pantoprazole

• Saline 0.9% (matching placebo)

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Switzerland	Dept. of Intensive Care Medicine, University of Bern,	Bern

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne	Rigshospitalet, Copenhagen, Denmark (Prof. Moller, Dr. Krag)

Countries where clinical trial is conducted

Denmark,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with clinically important GI bleeding		90 days or length of ICU stay, as applicable
Secondary	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		90 days or length of ICU stay, as applicable
Secondary	Proportion of patients with serious adverse reactions		90 days or length of ICU stay, as applicable
Secondary	Proportion of patients with one or more infectious adverse events (pneumonia or CDI) in the ICU		90 days or length of ICU stay, as applicable
Secondary	Days alive without use of mechanical ventilation, renal replacement therapy, or circulatory support in the 90-day period		90 days or length of ICU stay, as applicable
Secondary	90-day and 1-year (365 days) mortality post-randomization		90 days/365 days or length of ICU stay, as applicable
Secondary	Proportion of patients receiving treatment (interventions) to stop GI-bleeding (i.e. endoscopy/ open or laparoscopic surgery/ coiling).		90 days or length of ICU stay, as applicable
Secondary	Number of units of packed red blood cells (RBCs) transfused.		90 days or length of ICU stay, as applicable
Secondary	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.		90 day, 360 days, or length of ICU stay, as applicable

External Links

•   Homepage SUP-ICU RCT