Noseworthy 1987.
Methods | Open‐label randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 86 participants Number analysed: 86 participants Ranitidine
Antacids
Inclusion criteria
Exclusion criteria
Baseline imbalances: Groups were similar with respect to age, gender, and admission diagnosis. Acute and chronic respiratory failure were the most common causes for admission |
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Interventions |
Ranitidine
Antacids
Adherence to regimen: Quote: "Eightysix patients were randomised, 42 received ranitidine, 44 received antacids (malox: 42 and amphojel:3), 38 receiving ranitidine completed 48 hours of study while 23 continued up to 72 hours. Of the patients receiving antacids, 39 completed 48 hours of study, while 25 continued up to 76 hours" Duration of trial: ‐ Duration of follow‐up: ‐ |
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Outcomes |
Outcomes sought in review and reported in trial
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
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Notes |
Setting: Department of Adult Intensive Care, Royal Alexandria Hospitals, Edmonton, and the Division of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “Using a computer generated table of numbers, patients were assigned by restricted randomisation...” Comment: Method adopted to obtain random sequence generation is clearly mentioned in the study report |
Allocation concealment (selection bias) | Low risk | Comment: 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.Therefore, high risk of performance bias |
Blinding (detection bias) Clinically important upper GI bleeding | High risk | Comment: There was no clear definition for detecting clinically significant upper GI bleeding, and it is unclear whether the unblinded nature of the study influenced this outcome, which was otherwise objective in nature |
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: All other outcomes of interest were objective in nature. Therefore the likelihood of detection bias is low |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: Although 1 participant withdrew from each group during the course of the study, all randomised participants were part of the final analysis.Therefore there was no attrition bias |
Selective reporting (reporting bias) | Low risk | Comment: All intended outcomes have been reported |
Other bias | Low risk | Comment: no mention of the source of funding. No additional biases were detected |