NCT03098537.

Trial name or title	Effects of enteral nutrition on stress ulcer haemorrhage ‐ multi‐center randomised controlled trial
Methods	Open‐label parallel‐group randomised controlled study
Participants	Inclusion criteria Age ≥ 18 years Admission to ICU Expected to stay in ICU > 24 hours No contraindications to EN within first 24 hours after admission to intensive care unit Exclusion criteria Evidence of active GI bleeding during current hospitalisation before study entry Coagulopathy (PLT < 50.000, INR > 1.5, aPTT > 2 × control) Patients receiving acid‐suppressing drugs before admission Pregnancy or lactation History/documented gastric ulcer Burn > 30% body surface area Head injury or increased intracranial pressure Partial or complete gastrectomy Shock Multi‐system trauma Exposure to gastric irritant drugs Patients not giving informed consent
Interventions	Intervention: enteral nutrition + proton pump inhibitor Control: enteral nutrition only
Outcomes	Primary outcome GI bleeding (until discharge from ICU or cessation of enteral nutrition up to 4 weeks) Overt GI bleeding (presence of 'coffee ground' emesis haematemesis, melena, or haematochezia) Significant GI bleeding, defined by 3‐point decrease in haematocrit within 24 hours accompanied by overt GI bleeding or by an unexplained 6‐point decrease in haematocrit during any 48‐hour period Secondary outcome ‐
Starting date	August 2016
Contact information	kgundogan@erciyes.edu.tr
Notes	clinicaltrials.gov/ct2/show/record/NCT03098537

APACHE: Acute Physiologic Assessment and Chronic Health Evaluation.

aPTT: activated partial thromboplastin time.

CDI: Clostridium difficile infection.

CT: computed tomography.

DDAVP: desmopressin.

EN: enteral nutrition.

ESRD: end‐stage renal disease.

GI: gastrointestinal.

H2RA: histamine receptor‐2 antagonist.

hCG: human chorionic gonadotropin.

HIV: human immunodeficiency virus.

ICU: intensive care unit.

INR: international normalised ratio.

IV: intravenous.

NG: nasogastric.

NSAIDs: non‐steroidal anti‐inflammatory drugs.

OG: orogastric.

PLT: platelet blood test.

PPI: proton pump inhibitor.

PT: prothrombin time.

RBC: red blood cell.

RRT: rapid resolution therapy.

SAR: serious adverse reaction.

SDM: substitute decision‐maker.

TIA: transient ischaemic attack.