Borrero 1985.

Methods	Quasi‐randomised trial
Participants	Baseline characteristics Number randomised: 155 participants Number analysed: 155 participants Antacids Age (years; mean (SD)): 57 (‐) Number of participants (n): 75 Gender (male/female; n): 43/32 Sucralfate Age (years; mean (SD)): 61 (‐) Number of participants (n): 80 Gender (male/female; n): 45/35 Inclusion criteria Participants with 1 or more of the following risk factors for GI bleeding Hypotension Major surgical procedure Multiple trauma Renal failure Jaundice Respiratory failure Sepsis Participants from whom informed consent was obtained Exclusion criteria Patient not satisfying inclusion criteria Baseline imbalances: no statistically significant difference between sucralfate‐treated and antacid‐treated groups in numbers, age, and gender of participants. 130 participants (61 and 69 in each group) had undergone a major operation just before trial entry
Interventions	Antacids (Mylanta or Maalox) Dose (total/d): varied Duration of treatment (days): 2.54 Route: NG tube Intervention: hourly according to the following schedule: 30 mL if pH of the gastric aspirate was ≥ 3.5 and 60 mL if pH was < 3.5 Concomitant medications: NG tube was clamped for 55 minutes after drug administration. There was constant monitoring of cardiac, pulmonary, renal, hepatic, haematological, metabolic, and neurological parameters. Special attention was paid to the frequency of bowel movements, serum magnesium levels, and the appearance of a skin rash Sucralfate Dose (total/d): 5 g Duration of treatment (days): 2.9 Route: NG tube Intervention: 1 g of sucralfate was administered in 10 mL of water every 6 hours Concomitant medications: NG tube was clamped for 55 minutes after drug administration. There was constant monitoring of cardiac, pulmonary, renal, hepatic, haematological, metabolic, and neurological parameters. Special attention was paid to the frequency of bowel movements, serum magnesium levels, and the appearance of a skin rash Adherence to regimen: not clearly mentioned in the trial report Duration of follow‐up: Quote: “Patients were continued in the trial until the onset of gastrointestinal bleeding, until they were discharged from the critical care unit, or until nasogastric suction was discontinued. The patients’ clinical course was followed until they were discharged from the hospital”
Outcomes	Outcomes sought in review and reported in trial Clinically important GI bleeding defined as the occurrence of any 1 of the following 3 findings Frank blood or 'coffee ground' aspirate from the nasogastric tube Melena and a decline in haematocrit Three consecutive dark‐blue reactions on Gastroccult slides All‐cause mortality in ICU Participants requiring blood transfusion (nil) Adverse events of interventions Note: GI bleeding was tested for antacids 9 and 10 hours after initiating prophylaxis, and for sucralfate 8, 41, and 43 hours after initiating 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 Ease of administration
Notes	Setting: Long Island Jewish Medical Centre and Queens Hospital Centre Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Quote: "The study protocol was approved by the institutional review boards at Long island Jewish Medical Centre and Queens Hospital Centre" Informed consent: Quote: "Informed consent was obtained from the patient or immediate relative" 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: "Patients were randomly assigned to one of the two treatment regimens according to their date of birth"; "participants born on even days were given antacids and those born on odd days were administered sucralfate" Comment: This was a 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, 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 was judged as 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	Low risk	Comment: unclear on blinding of outcome assessors. However, outcomes of interest were objective in nature, so the likelihood of detection bias is low
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All randomised participants were part of 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