Skip to main content
. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

Ali 2016.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 10 participants
Number analysed: 10 participants
Pantoprazole
  • Age (years; mean (SD)): ‐ (‐)

  • Number of participants (n): 4

  • Gender (male/female; n): ‐


Placebo
  • Age (years, mean (SD)): ‐ (‐)

  • Number of participants (n): 6

  • Gender (male/female; n): ‐


Inclusion criteria
  • Receiving > 5 doses of pantoprazole/placebo

  • Being mechanically ventilated


Exclusion criteria:
Baseline imbalances:
Interventions Pantoprazole
  • Dose (total/d): 40 mg

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: IV pantoprazole (40 mg), mean 8.8 (0.3) doses

  • Concomitant medications: mechanical ventilation


Placebo
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: placebo, mean 10.7 (1.1) doses

  • Concomitant medications: ‐


Adherence to regimen:
Duration of trial:
Duration of follow‐up:
Outcomes Outcomes sought in review and reported in trial
  • Clinically important GI bleeding


Outcomes sought but not reported in trial
  • VAP

  • All‐cause mortality in hospital

  • Duration of ICU stay

  • Duration of intubation

  • Blood transfusions

  • Adverse events of interventions


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: mentioned only that participants were randomised to treatment. Not enough information on method of randomisation
Allocation concealment (selection bias) Unclear risk Comment: no information about allocation concealment reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: mentioned only that the trial was double‐blind. No information about the method of blinding
Blinding (detection bias) 
 Clinically important upper GI bleeding Low risk Comment: mentioned that outcome assessment was done blinded to intervention. Presence of 1 or more macroscopic abnormalities (erythema or oedema, erosions, ulcerations, and nasogastric tube lesions) and GI bleeding was assessed, blinded to intervention, at endoscopy by a single experienced gastroenterologist
Quote: "assessed, blinded to intervention, at endoscopy by a single experienced gastroenterologist"
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: The outcome was not addressed in this trial
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Low risk Comment: mentioned that outcome assessment was done blinded to intervention
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: Conference abstract reports about 10 participants from a larger prospective trial. Those who received > 5 doses of pantoprazole or placebo (n = 84) were eligible for the endoscopy substudy, but unclear why data from only 10 participants are reported
Selective reporting (reporting bias) Low risk Comment: Outcomes reported in Methods section are also reported in Results section
Other bias Unclear risk Comment: not enough information reported in conference abstract to assess other biases