Tryba 1985.

Methods	Open‐label randomised controlled trial
Participants	Baseline characteristics Number randomised:100 Number analysed: 100 Cimetidine Age (years; median (SD)): 55.8 (17.6) Number of participants (n): 33 Gender (male/female; n): 16/17 Antacids Age (years; median (SD)): 55.6 (14.7) Number of participants (n): 33 Gender (male/female; n): 8/25 Sucralfate Age (years; median (SD)): 57.1 (12.8) Number of participants (n): 34 Gender (male/female; n): 12/22 Inclusion criteria Total risk score of above 10 as devised by Tryba et al Being in the intensive care unit for at least 2 days Exclusion criteria Admission because of acute GI haemorrhage Gastric or duodenal ulcer in the preceding 12 months Baseline imbalances: Quote: "There were no statically significant differences among the three treatment groups on basic or laboratory parameters" Comment: The 3 groups were similar with respect to demographic data
Interventions	Cimetidine Dose (total/d): 2 g Duration of treatment (days): as long as the participant was in the ICU Route: IV Intervention: 2 g every 24 hours by continuous IV infusion Concomitant medications: All participants received 50 mg of pirenzepine daily. Enteral feeding was administered to all stable participants. Potassium phosphate was given routinely (0 to 140 mmol daily) Antacids Dose (total/d): 120 mL Duration of treatment (days): as long as the participant was in the ICU Route: ‐ Intervention: 10 mL antacid containing aluminium hydroxide and calcium carbonate every 2 hours Concomitant medications: All participants received 50 mg of pirenzepine daily. Enteral feeding was administered to all stable participants. Potassium phosphate was given routinely (0 to 140 mmol daily) Sucralfate Dose (total/d): 6 g Duration of treatment (days): as long as the participant was in the ICU Route: ‐ Intervention: 1 g of sucralfate was given every 4 hours Concomitant medications: All participants received 50 mg of pirenzepine daily. Enteral feeding was administered to all stable participants. Potassium phosphate was given routinely (0 to 140 mmol daily) Adherence to regimen: Quote: "... nausea and vomiting led to the discontinuation of antacid in four patients. The interval between administration of antacid doses had to be extended to four hours in 18 patients following the removal of their stomach tubes because they refused more frequent doses. Moreover, antacids could not be administered every two hours during the night in patients without a stomach tube since it was unreasonable to awaken them repeatedly for this purpose. Nausea or vomiting occurred in nine patients receiving sucralfate following the removal of the stomach tubes. This necessitated discontinuing the drug in one patient and changing the dosage interval to eight hours in four patients" Duration of trial: September 1982 to December 1983 Duration of follow up: not clearly mentioned in the study report. Probably until death or discharge
Outcomes	Outcomes sought in review and reported in trial Primary outcomes Acute upper GI haemorrhage: macroscopically visible bleeding (haematemesis, bloody aspirate, or melena) as the criteria for acute upper GI bleeding Secondary outcomes All‐cause mortality in ICU Adverse events due to interventions Outcomes sought but not reported in trial Incidence of ventilator‐associated pneumonia All‐cause mortality in hospital Duration of ICU stay Duration of intubation Number of participants requiring blood transfusion Units of blood transfused Outcomes reported but not used in review Gastric pH values
Notes	Setting: Department of Anaesthesiology and Biometry Hannover School of Medicine, Hannover, Federal Republic of Germany Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Quote: "The study was carried out from September 1982 to December 1983 with institutional approval and in accordance with the guidelines of the German Drug Law" Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not clearly mentioned in the study report
Allocation concealment (selection bias)	Unclear risk	Comment: not clearly mentioned in the study report
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: This was not a placebo‐controlled trial, and the different modes of administering study interventions would not have made it possible to blind study personnel and participants
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: unclear whether outcome assessors were blinded. However, GI bleeding was an objective outcome that was detected as per the definition in the study protocol
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: Study did not address this outcome
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Low risk	Comment: All other outcomes of interest were objective in nature
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All randomised participants were part of the analysis
Selective reporting (reporting bias)	Low risk	Comment: All intended outcomes were analysed and reported
Other bias	Low risk	Comment: unclear on the source of funding. No other form of bias detected