Borrero 1984.

Methods	Quasi‐randomised controlled trial
Participants	Baseline characteristics Number randomised: 100 participants Number analysed: 100 participants Antacids Age (years; mean (SD)): 57 (‐) Number of participants (n): 52 Gender (male/female; n): 31/21 Sucralfate Age (years; mean (SD)): 62.2 (‐) Number of participants (n): 49 Gender (male/female; n): 27/21 Inclusion criteria Patient admitted to medical or surgical ICU Exclusion criteria Receiving fluids or food by mouth Having undergone cardiac, gastric, or oesophageal surgery Evidence of gross upper GI bleeding upon entry into the trial Baseline imbalances: Quote: "There was no statistically significant difference between the sucralfate treated and the antacid treated groups in number of patients, sex" Comment: Average numbers of risk factors per group were also similar; 92.5 and 83 participants had undergone an operation just before trial entry
Interventions	Antacids (Mylanta II) Dose (total/d): varied Duration of treatment (days): Until oral feedings began, NG tube was removed and patient was discharged from the ICU Route: NG tube Intervention: initial dose of 30 mL via NG tube. With pH < 3.5, dosage was progressively doubled until subsequent pH was > 3.5. Amphojel was substituted for Mylanta II in participants with severe diarrhoea and renal failure. In case of GI bleed, the last dose was doubled and the participant continued to receive that dose every hour 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 < 150 mL Sucralfate Dose (total/d): 4 g Duration of treatment (days): Until oral feedings began, NG tube was removed and participant was discharged from ICU Route: NG tube Intervention: 1 g of sucralfate was administered in 30 mL of normal saline solution through NG tube followed by an additional gram every 6 hours (no dose changes were performed based on pH determinations) Concomitant medications: In case of GI bleed, sucralfate was discontinued and antacids started. The NG tube was clamped in all participants for 1 hour after administration. If regurgitation occurred around the tube or if 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: Quote: "Of the 52 patients treated with antacids, failure to achieve a pH of 3.5 or greater occurred in 8 patients initially given 30 mL of antacid. Five subsequently required 60 mL/hour and three required 120 mL/hour. All patients receiving antacids maintained a gastric pH of mote than 5" Comment: Iced saline solution lavage was given to all participants with diagnosis of upper GI bleed (by Gastroccult test) Duration of trial: August 1983 to December 1983 Duration of follow up: probably until discharge or death
Outcomes	Outcomes sought in review and reported in trial Clinically important GI bleeding defined as occurrence of any one of the following 3 findings Frank or occult bleeding every hour or 3 consecutive dark‐blue reactions (Gastroccult paper test) Number of participants requiring blood transfusions (nil) All‐cause mortality in ICU Adverse events of interventions Note: antacids 9 and 10 hours after start of the drug and sucralfate; 8, 41, and 45 hours after initiation of prophylaxis Outcomes sought but not reported in trial 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 Nursing time required
Notes	Setting: Queens Hospital Centre, New York, USA Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: No deaths were due to GI bleeding
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quote: “100 patients admitted to medical and surgical intensive care units were randomised to receive either antacids and sucralfate depending on the year of birth (odd year, sucralfate; even year, antacid)” Comment: This was a quasi‐randomised trial
Allocation concealment (selection bias)	High risk	Comment: This was a quasi‐randomised trial, and no information on allocation concealment was reported
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: no information on blinding reported
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: Blinding was not done. However, the outcome was measured as per the definition used in the trial protocol. Moreover, owing to the objective nature of the outcome of interest, the likelihood of detection and performance bias is low
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: no information on blinding or criteria to diagnose other outcomes reported
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 detected