Sup-Icu RENal (SIREN) (SIREN)
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| ClinicalTrials.gov Identifier: NCT02718261 |
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Recruitment Status :
Completed
First Posted : March 24, 2016
Last Update Posted : September 11, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Critical Illness Acute Kidney Injury End-stage Renal Disease Renal Replacement Therapy Proton Pump Inhibitor | Drug: Pantoprazole Drug: Saline 0.9% (matching placebo) | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3350 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Other |
| 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 |
| Actual Study Start Date : | February 2016 |
| Actual Primary Completion Date : | September 2018 |
| Actual Study Completion Date : | September 2018 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Verum (pantoprazole) |
Drug: Pantoprazole |
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Placebo Comparator: Placebo
0.9% saline
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Drug: Saline 0.9% (matching placebo) |
- The proportion of patients with clinically important GI bleeding [ Time Frame: 90 days or length of ICU stay, as applicable ]
- 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 ]
- Proportion of patients with serious adverse reactions [ Time Frame: 90 days or length of ICU stay, as applicable ]
- 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 ]
- 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 ]
- 90-day and 1-year (365 days) mortality post-randomization [ Time Frame: 90 days/365 days or length of ICU stay, as applicable ]
- 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 ]
- Number of units of packed red blood cells (RBCs) transfused. [ Time Frame: 90 days or length of ICU stay, as applicable ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- please refer to SUP-ICU (NCT02467621) trial
Exclusion Criteria:
- please refer to SUP-ICU (NCT02467621) trial
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718261
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
| Switzerland | |
| Dept. of Intensive Care Medicine, University of Bern, | |
| Bern, Switzerland, 3010 | |
Study Data/Documents: Study Protocol
SUP-ICU Website
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jörg Schefold, SIREN principle investigator, University Hospital Inselspital, Berne |
| ClinicalTrials.gov Identifier: | NCT02718261 |
| Other Study ID Numbers: |
SIREN |
| First Posted: | March 24, 2016 Key Record Dates |
| Last Update Posted: | September 11, 2018 |
| Last Verified: | September 2018 |
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Acute Kidney Injury Kidney Failure, Chronic Critical Illness Renal Insufficiency Kidney Diseases Urologic Diseases Renal Insufficiency, Chronic Disease Attributes |
Pathologic Processes Pantoprazole Anti-Ulcer Agents Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |