Borrero 1986.

Methods	Quasi‐randomised trial
Participants	Baseline characteristics Number randomised: 50 participants Number analysed: 50 participants Antacids Age (years; mean (SD)): 67.1 (‐) Number of participants (n): 25 Gender (male/female; n): 19/6 Sucralfate Age (years; mean (SD)): 67.9 (‐) Number of participants (n): 25 Gender (male/female; n): 19/6 Inclusion criteria Underwent abdominal aortic surgery Admitted to surgical ICU Exclusion criteria Simultaneously underwent gastric or duodenal surgery History of peptic ulcer disease Baseline imbalances: Quote: "There was no statistically significant difference between the sucralfate treated and the antacid treated groups in number of patients, sex, mean age [...] or number of risk factors per patient" Comment: All participants had undergone aortobifemoral artery Dacron graft placement
Interventions	Antacids (Mylanta II) Dose (total/d): 30 mL Duration of treatment (days): until oral feedings began, NG tube was removed, and participant was discharged from ICU Route: NG tube Intervention: Participants received 30 mL of a commercial antacid through NG tube. Each hour, the tube was clamped and participant was placed on suction for 5 minutes Concomitant medications: NG tube was clamped in all participants for 1 hour after administration. If regurgitation occurred around the tube, or if the volume exceeded 150 mL at the end of 1 hour, the tube was clamped for 30 minutes and suction applied for the next 30 minutes, until aspirate was less than 150 mL Sucralfate Dose (total/d): 4 grams Duration of treatment (days): until oral feedings began, NG tube was removed, and participant was discharged from ICU Route: NG tube Intervention: 1 gram suspended in 30 mL of normal saline solution through NG tube followed by 10 mL of normal saline solution every 6 hours to clear the NG tube of any adherent sucralfate Concomitant medications: NG tube was clamped in all participants for 1 hour after administration. If regurgitation occurred around the tube, or if the volume exceeded 150 mL at the end of 1 hour, the tube was clamped for 30 minutes and suction applied for the next 30 minutes, until aspirate was less than 150 mL Adherence to regimen: Comment: Iced saline solution lavage was given to all participants with diagnosed upper GI bleeding Duration of trial: August 1983 to December 1984 Duration of follow‐up: not clearly mentioned in the trial report; probably until discharge or death
Outcomes	Outcomes sought in review and reported in trial Primary outcomes Clinically important GI bleeding defined as the occurrence of Frank blood in the aspirate Uniformly dark blue reaction on 3 consecutive readings All‐cause mortality in ICU Participants requiring blood transfusion Adverse events of interventions Outcomes sought but not reported in trial report VAP Duration of ICU stay Duration of intubation All‐cause mortality in hospital Number of units of blood transfused Outcomes reported in trial but not used in review Cost‐effectiveness
Notes	Settings: Long island Jewish Medical Centre, New Hyde Park, NY 11042 Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: None of the deaths were due to GI bleeding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: "…were randomised to receive either antacid or sucralfate, depending on their year of birth (odd year sucralfate, even year antacid) Comment: quasi‐randomised trial
Allocation concealment (selection bias)	High risk	Comment: This was a quasi‐randomised trial; no information on method of allocation concealment was reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: This was not a placebo‐controlled trial; the different interventions and their mode of administration might not have ensured blinding of personnel
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: unclear on blinding of outcome assessors. However, GI bleeding was an objective outcome that was detected as per the definition used in the trial report
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: The trial did not address this outcome
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Unclear risk	Comment: unclear on blinding of outcome assessors
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All randomised participants were included in the final analysis
Selective reporting (reporting bias)	Low risk	Comment: All intended outcomes were analysed and reported
Other bias	Low risk	Comment: Source of funding is unclear. No other source of bias is suspected