De Azevedo 2000.

Methods	Randomised controlled trial
Participants	Baseline characteristics Number randomised: ‐ Number analysed: ‐ Ranitidine Age (years; mean (SD)): 57.3 (19.3) Number of participants (n): 38 Gender (male/female; n): 19/19 Sucralfate Age (years; mean (SD)): 56.9 (20.5) Number of participants (n): 32 Gender (male/female; n): 18/14 Omeprazole Age (years; mean (SD)): 56.0 (18.9) Number of participants (n): 38 Gender (male/female; n): 19/19 Inclusion criteria Age > 14 years Admitted to São Domingos Hospital during the period 28 Feb. 1997 to 06 Apr 1998 Having ≥ 1 risk factor for stress ulcer bleeding (stroke with Glasgow score < 10, coagulopathy, steroid therapy, anticoagulant therapy, liver failure, acute renal failure, respiratory failure, severe acute pancreatitis, burns > 30% of body surface, sepsis and septic shock, head injury with Glasgow score  < 10) Exclusion criteria Pregnancy Stress ulcer bleeding at admission Baseline imbalances: Groups were similar to each other with respect to demographic characteristics. APACHE ll scores were 55.7 ± 23.2, 54.1 ± 21.7, and 56.1 ± 23.7 in the ranitidine, sucralfate, and omeprazole groups, respectively. Pneumonia was present in 2, 3, and 3 participants in the 3 groups
Interventions	Ranitidine Dose (total/d): 150 mg Duration of treatment (days): ‐ Route: IV Intervention: 150 mg of continuous intravenous infusion per day, diluted in 100 mL saline, administered with the aid infusion pump Concomitant medications: corticosteroids Sucralfate Dose (total/d): 4 g Duration of treatment (days): ‐ Route: intragastric tube Intervention: tablet of 1 g of sucralfate, homogenised and diluted in 20 mL of water every 6 hours by tube feeding; In patients who showed siphoning probe, the tube was held closed for 1 hour after drug administration Concomitant medications: corticosteroids Omeprazole Dose (total/d): 80 mg Duration of treatment (days): ‐ Route: IV Intervention: intravenous, 40 mg every 12 hours Concomitant medications: corticosteroids Adherence to regimen: ‐ Duration of trial: February 1997 to April 1998 Duration of treatment: Duration of treatment that was established was based on clinical evaluation, control of risk factors, clinical improvement, and full nutritional support, oral or enteral Duration of follow‐up: during the period that participants were in the ICU. Probably until death or discharge
Outcomes	Outcomes sought in review and reported in trial Clinically important upper GI bleeding VAP All‐cause mortality in ICU Number of participants requiring blood transfusion Outcomes sought but not reported in trial Number of units of blood transfused All‐cause mortality in hospital Duration of ICU stay Duration of intubation Adverse events of interventions Outcomes reported in trial but not used in review Intragastric pH status Gastric colonisation
Notes	Setting: Intensive Care Unit, Hospital São Domingos, Sao Luis do Maranhão, Brasil Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The patients were randomly assigned for one of the three groups when they were admitted for the intensive unit care, they used a simple technique of randomisation, and sealed envelopes" Comment: not enough information on sequence generation reported
Allocation concealment (selection bias)	Unclear risk	Comment: Trial authors described that they used sealed envelopes. It was not stated whether they were numbered and opaque
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Comment: not enough information reported
Blinding (detection bias) Clinically important upper GI bleeding	Unclear risk	Comment: not enough information reported on criteria for assessment of upper GI bleeding
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: not enough information reported on criteria for assessment of pneumonia
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Low risk	Comment: unclear; however all other outcomes of interest were objective outcomes. Therefore the likelihood of performance and detection bias is low
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: All randomised participants were analysed
Selective reporting (reporting bias)	Low risk	Comment: All outcomes described in the Methods section were analysed in the Results section
Other bias	Low risk	Comment: no other source of bias detected