Ruiz‐Santana 1991.

Methods	Single‐blind randomised controlled trial
Participants	Baseline characteristics Number randomised: 94 participants Number analysed:73 participants Total parenteral nutrition (TNP) Age (years; mean (SD)): 39 (14) Number of participants (n): 30 Gender (male/female; n): 19/11 TPN + sucralfate Age (years; mean (SD)): 37 (18) Number of participants (n): 24 Gender (male/female; n): 20/4 TPN + ranitidine Age (years; mean (SD)): 39 (17) Number of participants (n): 19 Gender (male/female; n): 14/5 Inclusion criteria Patients having metabolic stress Stable haemodynamically Normal hepatic and renal function On total parenteral nutrition  Exclusion criteria Patients with spinal cord injuries History of gastroduodenal ulcer in the 12 months preceding ICU admission Operations of the upper GI tract Active GI tract haemorrhage Hepatic or renal failure, with catabolic index ≤ 0 Patients who received antacids, H2 blockers, or sucralfate within the past 48 hours before study entry Baseline imbalances: Groups were similar with respect to age and gender. The 2 main reasons for admission were respiratory disease (n = 26) and multiple injuries (n = 14). There is no clear mention of the distribution of clinical features across study groups
Interventions	TPN Dose (total/d): 1500 mL Duration of treatment (days): min 6 Route: ‐ Intervention: 1500 mL of total parenteral nutrition (1600 kcal, 99 g protein,150 g glucose, and 100 g fat, with electrolytes, minerals, and vitamins) Concomitant medications: ‐ TPN + sucralfate Dose (total/d): 6 g Duration of treatment (days): min. 6 Route: NG tube Intervention: 1 g via NG tube every 4 hours, which is then flushed with 15 mL of water to prevent clogging + parenteral nutrition Concomitant medications: ‐ TPN + ranitidine Dose (total/d): 200 mg Duration of treatment (days): min 6 Route: IV Intervention: 50 mg IV every 6 hours + parenteral nutrition Concomitant medications: ‐ Adherence to regimen: Quote: "24 participant were withdrawn from the study before the sixth day on protocol with the following reasons for withdrawal: weaned from mechanical ventilation before the sixth day (n = 10), death (n = 8), acute upper GI haemorrhage (n = 5, 2 stress induced gastroduodenal ulcers, 2 chronic duodenal ulcers, 1 stomach cancer) and early tolerance to enteral feedings (n = 1)" Comment: The interventional arms to which these participants were initially randomised are not clearly mentioned in the study report Duration of trial: December 1988 to January 1990 Duration of follow up: not mentioned in the study report. Probably until death or discharge
Outcomes	Outcomes sought in review and reported in trial Incidence of upper GI bleeding: clinical signs of haematemesis, bloody aspirate, melena,'coffee ground' material followed by endoscopic examinations to determine the actual bleeding site All‐cause mortality in ICU Duration of intubation Outcomes sought but not reported in trial Incidence of ventilator‐associated pneumonia All‐cause mortality in hospital Participants requiring blood transfusion Units of blood transfused Adverse events of interventions Outcomes reported but not used in review Catabolic index score APACHE II score
Notes	Setting: ICU and gastroenterology service, Hospital del Pino, Las Palmas de Gran Canaria, Canary Islands, Spain Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Quote: "The study was approved by the institutional review board" Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Commets: not clearly mentioned in the study report
Allocation concealment (selection bias)	Unclear risk	Commets: not clearly mentioned in the study report
Blinding of participants and personnel (performance bias) All outcomes	High risk	Comment: This was not a placebo‐controlled trial, and the different modes of administering study interventions would not have made it possible to blind study personnel and participants
Blinding (detection bias) Clinically important upper GI bleeding	Low risk	Quote: ”All endoscopic examinations, except a few cases performed on emergency basis was done by a single investigator uninformed as to the treatment group” Comment: Outcome assessors were mostly blinded and GI bleeding was an objective outcome that was detected as per the definition in the study protocol
Blinding (detection bias) Nosocomial pneumonia	Unclear risk	Comment: Study did not address this outcome
Blinding of outcome assessment (detection bias) Adverse reactions of interventions	Low risk	Comment: unclear on the blinding of outcome assessors. However, all other outcomes were objective in nature
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: Of the 97 participants, 24 were withdrawn from the study, as they did not complete a minimum of 6 days in the ICU as required by the protocol of this study. The interventions to which they were originally randomised were not clear from the study report. A per‐protocol analysis was done for the outcomes of interest, but there appears to be an imbalance between groups with respect to the final number of participants available for analysis
Selective reporting (reporting bias)	Low risk	Comment: All intended outcomes were analysed and reported
Other bias	Unclear risk	Comment: Source of funding is not clearly stated. Baseline characteristics (clinical) are not clearly mentioned for each group. No additional biases were detected