Khorvash 2014.
Methods | Parallel‐group quasi‐randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 148 participants Number analysed: 137 participants Pantoprazole
Sucralfate
Inclusion criteria
Exclusion criteria
Baseline imbalance: ‐ |
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Interventions |
Pantoprazole
Sucralfate
Adherence to regimen: ‐ Duration of trial: early 2010 to mid‐2011 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 but not used in review
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Notes |
Setting: ICU, Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: Study was approved by the medical universities ethics committee at Isfahan University of Medical Sciences Informed consent: Quote: "after they agreed to cooperate" Comment: included in the trial report Clinical trials registration: ‐ Sample size calculation: ‐ |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Patients were consecutively assigned to each group. The first patient was selected randomly" Comment: no randomisation, quasi‐randomised study |
Allocation concealment (selection bias) | High risk | Comment: consecutive pattern of allocation |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: no blinding reported, but lack of blinding is unlikely to introduce bias to outcome measures or outcomes |
Blinding (detection bias) Clinically important upper GI bleeding | Unclear risk | Comment: Study did not address this outcome |
Blinding (detection bias) Nosocomial pneumonia | Low risk | Quote: "Ventilator‑associated pneumonia is defined as a group of pneumonias that occur 48 hours after the patient is ventilated if the patient did not have primary signs of the infection at the time of arriving ICU. VAP is one of the most prevalent nosocomial infections and pneumonia is causes 27% of infections in ICU" Comment: Criteria for diagnosis of the outcome were reported objectively |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Unclear risk | Comment: no blinding of outcome assessors described |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comment: "11 patients were excluded for different reasons like not using the drug, changing the drug by the physician, and so on. Three of them were from the pantoprazole and 8 of them were from sucralfate group" |
Selective reporting (reporting bias) | Unclear risk | Comment: no outcomes of interest described in the Methods section; assessment of selective outcome reporting difficult |
Other bias | Low risk | Comment: no other sources of bias suspected |