NCT02718261.

Trial name or title	Sup‐Icu RENal (SIREN) ‐ a subanalysis of the prospective SUP (stress ulcer prophylaxis)‐ICU trial on the risk of GI bleeding in ICU patients receiving renal replacement therapy
Methods	Parallel‐group triple‐blind randomised controlled study
Participants	Inclusion criteria Acute admission to ICU Age ≥ 18 years ≥ 1 of the following risk factors: Shock (continuous infusion with vasopressors or inotropes, systolic blood pressure < 90 mmHg, mean arterial blood pressure < 70 mmHg, or lactate > 4 mmol/L) Acute or chronic intermittent or continuous renal replacement therapy Invasive mechanical ventilation that is expected to last > 24 hours Coagulopathy (platelets < 50 × 10⁹/L or international normalized ratio (INR) > 1.5 or prothrombin time (PT) > 20 seconds) documented within the last 24 hours Ongoing treatment with anticoagulant drugs (prophylaxis doses excluded) History of coagulopathy (platelets < 50 × 10⁹/L or INR > 1.5 or PT > 20 seconds) within 6 months before hospital admission History of chronic liver disease (portal hypertension, cirrhosis proven by biopsy, computed tomography (CT) scan or ultrasound, history of variceal bleeding or hepatic encephalopathy in the past medical history) Exclusion criteria Contraindications to PPI Ongoing treatment with PPI and/or H2RA on a daily basis GI bleeding of any origin during current hospital admission Diagnosis of peptic ulcer during current hospital admission Organ transplant during current hospital admission Withdrawal from active therapy or brain death Fertile woman with positive urine human chorionic gonadotropin (hCG) or plasma hCG Consent according to national regulations not obtainable
Interventions	Intervention: pantoprazole IV Control: 0.9% saline IV
Outcomes	Primary outcome Clinical GI bleeding episodes undergoing RRT within first 3 days following ICU admission ("RRT group") vs in patients without the need for RRT during ICU stay ("control group") Secondary outcomes Adverse events: clinically important GI bleeding, pneumonia, Clostridium difficile infection, or acute myocardial ischaemia in the ICU Serious adverse reactions 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 90‐Day and 1‐year (365 days) mortality post randomisation 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
Starting date	February 2016
Contact information	Joerg Schefold; joerg.schefold@insel.ch
Notes	clinicaltrials.gov/ct2/show/record/NCT02718261