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. 2018 Jun 4;2018(6):CD008687. doi: 10.1002/14651858.CD008687.pub2

Selvanderan 2015.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 214 participants
Number analysed: 214 participants
Pantoprazole
  • Age (years; mean (SD)): ‐ (‐)

  • Number of participants (n): ‐

  • Gender (male/female; n): ‐


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

  • Number of participants (n): ‐

  • Gender (male/female; n): ‐


Inclusion criteria
  • Anticipated to require mechanical ventilation for > 24 hours

  • Commence enteral nutrition within 48 hours of admission


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

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: ‐

  • Concomitant medications: ‐


Placebo
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: ‐

  • Intervention: ‐

  • Concomitant medications: ‐


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
  • Incidence of clinically important GI bleeding

  • Incidence of VAP

  • All‐cause mortality in hospital


Outcomes sought but not reported in trial
  • Duration of ICU stay

  • Duration of intubation

  • Adverse events of interventions


Outcomes reported in trial but not used in review
  • Clostridium difficile infection

  • Daily haemoglobin concentrations

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