NCT02157376.

Trial name or title	Stress ulcer prophylaxis of intravenous esomeprazole in Chinese seriously ill patients (SUP)
Methods	Double‐blind parallel‐group randomised controlled study
Participants	Inclusion criteria Critically ill patients Requirement for mechanical ventilation ≥ 1 major risk factor for stress ulcer‐related bleeding Exclusion criteria History of gastric or oesophageal surgery Evidence of active GI bleeding Advanced renal disease Treatment with any proton pump Inhibitors
Interventions	Intervention: IV esomeprazole 30 min intermittent infusions given for maximum 14 days Control: IV cimetidine 30 min bolus infusion followed by IV cimetidine continuous infusion given for maximum 14 days
Outcomes	Primary outcome Percentage of patients with clinically significant upper GI bleeding during treatment evaluation phase defined as: Bright red blood per NG or OG tube that did not clear after NG or OG tube adjustment and 5 to 10 minutes of ≥ 100 mL lavage with room temperature normal saline Persistent Gastroccult‐positive 'coffee ground' material During IMP treatment days 1 and 2: persistent Gastroccult‐positive 'coffee ground' material for ≥ 8 consecutive hours that did not clear with ≥ 100 mL of lavage with room temperature normal saline During IMP treatment days 3 to 14: persistent Gastroccult‐positive 'coffee ground' material in ≥ 3 consecutive gastric aspirates within 2 to 4 hours (≥ 60 ± 20 minutes apart) that did not clear with ≥ 100 mL of lavage with room temperature normal saline Secondary outcomes Any overt upper GI bleeding (significant and non‐significant) during treatment evaluation phase defined as in criteria for a significant upper GI bleeding as described in primary outcome measure or Bright red blood per NG or OG tube that clears after NG or OG tube adjustment and 5 to 10 minutes of lavage with room temperature normal saline Persistent Gastroccult‐positive 'coffee ground' material During IMP treatment days 1 to 2: persistent Gastroccult‐positive 'coffee ground' material for < 8 consecutive hours or that clears with ≥ 100 mL of lavage with room temperature normal saline During IMP treatment days 3 to 14: persistent Gastroccult‐positive 'coffee ground' material in < 3 consecutive gastric aspirates within 2 to 4 hours (≥ 60 ± 20 minutes apart) or that clear with ≥ 100 mL of lavage with room temperature normal saline Any clinical signs of haematemesis or melena or haematochezia judged (by the investigator) to be from an upper GI source
Starting date	July 2014
Contact information	Xinyu Qin, Professor and Chairman, Department of General Surgery, Zhongshan, Hospital, Fudan University
Notes	clinicaltrials.gov/ct2/show/record/NCT02157376