Fogas 2013.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 94 participants Number analysed: 79 participants Proton pump inhibitors
H2 receptor antagonists
Inclusion criteria
Exclusion criteria
Baseline imbalances: no significant difference (P > 0.05) between groups regarding demographics |
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Interventions |
Proton pump inhibitors
H2 receptor antagonists
Adherence to treatment: ‐ Duration of follow‐up: ‐ Duration of trial: ‐ |
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Outcomes |
Outcomes reported in trial and used in review
Outcomes sought but not reported in trial
Outcomes reported in trial but not used in review
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Notes |
Setting: General ICU, University of Szeged, Hungary Sponsorship source: ‐ Conflicts of interest: ‐ Comments: conference abstract Ethics approval: Quote: "After ethics committee approval ..." Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: Quote: "However, the completion of the study on the planned 198 patients is required to come to the final conclusions" |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: no details reported |
Allocation concealment (selection bias) | Unclear risk | Comment: no details reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: no details reported, but lack of blinding unlikely to introduce bias to the outcome and outcome measures |
Blinding (detection bias) Clinically important upper GI bleeding | High risk | Comment: no details reported, and no diagnostic criteria described |
Blinding (detection bias) Nosocomial pneumonia | Low risk | Comment: Pneumonia was an objective outcome that was diagnosed as per the definition in the study protocol |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Unclear risk | Comment: no details reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no incomplete reporting of outcome data. Patient flow was reported transparently; attrition was unlikely to have introduced bias to the results |
Selective reporting (reporting bias) | Low risk | Comment: All outcomes listed are reported in the Results section. Conference abstract |
Other bias | Unclear risk | Comment: no other sources of bias suspected, but not enough details reported in conference abstract |