Darlong 2003.

Methods	Open‐label randomised controlled trial
Participants	Baseline characteristics Number randomised: 52 participants Number analysed: 52 participants Ranitidine Age (years; mean (SD)): 43.95 (18.46) Number of participants (n): 24 Gender (male/female; n): 11/13 Sucralfate Age (years; mean (SD)): 39.6 (15.24) Number of participants (n): 21 Gender (male/female; n): 14/7 No prophylaxis Age (years; mean (SD)): 39.16 (19.52) Number of participants (n): 7 Gender (male/female; n): 3/4 Inclusion criteria Intubated for mechanical ventilation likely to last > 24 hours Nasogastric tube in place was included in the study Exclusion criteria Active upper gastrointestinal haemorrhage receiving antacids, H2 receptor antagonist, or sucralfate in the previous 24 hours Receiving anticoagulants Coagulopathy Baseline imbalances: There were no major differences in demographic profiles between study groups Comment: Participants were from medical and surgical units, in equal proportions across the 3 groups. However, the underlying reason for admission is not mentioned in the trial report
Interventions	Ranitidine Dose (total/d): 150 mg Duration of treatment (days; mean (SE)): ‐ Route: IV Intervention: intravenous ranitidine at a standard dose of 50 mg every 8 hours Concomitant medications: Nutrition was provided through the parenteral route until completion of the trial Sucralfate Dose (total/d): 3 g Duration of treatment (days; mean (SE)): ‐ Route: Intervention: sucralfate tablet,1 g 8‐hourly crushed to powder Concomitant medications: Nutrition was provided through the parenteral route until completion of the trial No prophylaxis Dose (total/d): ‐ Duration of treatment (days; mean (SE)): ‐ Route: ‐ Intervention: ‐ Concomitant medications: Nutrition was provided through the parenteral route until completion of the trial Adherence to regimen: ‐ Duration of trial: ‐ Duration of follow‐up: probably until death or discharge
Outcomes	Outcomes sought in review and reported in trial Clinically Important GI bleeding defined as observation of fresh blood or blood of 'coffee ground' colour in the gastric aspirate Outcomes sought but not reported in trial VAP All‐cause mortality in ICU All‐cause mortality in hospital Duration of ICU stay Duration of intubation Number of participants requiring blood transfusion Number of units of blood transfused Adverse events of interventions Outcomes reported in trial but not used in review Intragastric pH status Gastric colonisation Gastric ulcerations BAL cultures
Notes	Setting: All India Institute of Medical Sciences (AIIMS), New Delhi, India Source of funding: Quote: "Supported by the Medical Research Council of Canada and Hoechst Marion Roussel. Drugs were supplied by Glaxo Wellcome, Baxter, and Hoechst Marion Roussel. Dr. Cook is a Career Scientist of the Ontario Ministry of Health" Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional Notes: Gram‐negative organisms were found in the gastric culture of 18 ranitidine participants and 6 sucralfate participants, and the control group had no pathogenic organisms. Pseudomonas was the most common organism in the gastric and BAL cultures of the ranitidine and sucralfate groups
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Comment: not clearly mentioned in the trial report
Allocation concealment (selection bias)	Unclear risk	Comment: not clearly mentioned in the trial report
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: This was not a placebo‐controlled trial, and the mode of administration of interventions could not have permitted blinding of participants. Therefore, high risk of performance bias
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Comment: not clearly mentioned in the trial report. However owing to the objective nature of the outcome, which was detected as per the trial protocol, the likelihood of performance and detection bias is low
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: Trial did not address this outcome
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Low risk	Comment: No other outcomes of interest were assessed in this trial
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	High risk	Comment: unclear on source of funding. Baseline imbalance on the numbers randomised to the 3 groups as the no prophylaxis arm had only 7 participants compared with 21 in the sucralfate arm and 24 in the ranitidine arm