Sup-Icu RENal (SIREN)

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Pantoprazole
* Drug: Saline 0.9% (matching placebo)


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum (pantoprazole)<br> | Drug: Pantoprazole<br> <br> |
| Placebo Comparator: Placebo<br>0.9% saline | Drug: Saline 0.9% (matching placebo)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with clinically important GI bleeding |  | 90 days or length of ICU stay, as applicable | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of patients with serious adverse reactions |  | 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 |  | 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 |  | 90 days or length of ICU stay, as applicable | 
| 90-day and 1-year (365 days) mortality post-randomization |  | 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). |  | 90 days or length of ICU stay, as applicable | 
| Number of units of packed red blood cells (RBCs) transfused. |  | 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. |  | 90 day, 360 days, or length of ICU stay, as applicable |