Selvanderan 2015.
Methods | Parallel‐group randomised controlled trial | |
Participants |
Baseline characteristics Number randomised: 214 participants Number analysed: 214 participants Pantoprazole
Placebo
Inclusion criteria
Exclusion criteria: ‐ Baseline imbalances: ‐ |
|
Interventions |
Pantoprazole
Placebo
Adherence to regimen: ‐ Duration of trial: January 2014 to January 2015 Duration of follow‐up: 90 days |
|
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
|
|
Notes |
Setting: ICU Source of funding: ‐ Conflicts of interest: ‐ Ethics approval: ‐ Informed consent: ‐ Clinical trials registration: ‐ Sample size calculation: ‐ Additional notes: ‐ |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not enough details reported |
Allocation concealment (selection bias) | Unclear risk | Comment: no details reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "double blind fashion" Comment: no details on blinding reported. Lack of blinding is unlikely to introduce bias to outcome measures or outcomes |
Blinding (detection bias) Clinically important upper GI bleeding | Low risk | Quote: "(haematemesis, bloody gastric aspirate, melaena or haematochezia), clinically significant bleeding (overt bleeding accompanied by a drop in mean arterial pressure > 20mmHg, or reduction in haemoglobin > 20g/L, or need for surgical intervention)" Comment: criteria for diagnosis of GI bleeding described. |
Blinding (detection bias) Nosocomial pneumonia | Unclear risk | Comment: no criteria for diagnosis of VAP described |
Blinding of outcome assessment (detection bias) Adverse reactions of interventions | Unclear risk | Comment: no information about blinding of outcome assessors described |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: not enough information reported to assess incomplete outcome data. Conference abstract |
Selective reporting (reporting bias) | Low risk | Comment: no incomplete reporting of outcomes suspected. All outcomes listed in the Methods section were also reported in the Results section briefly |
Other bias | Unclear risk | Comment: no other sources of bias suspected, but very little information reported overall |