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

Fogas 2013.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 94 participants
Number analysed: 79 participants
Proton pump inhibitors
  • Age (years; mean (range)): 67 (56‐77)

  • Number of participants at baseline (n): 38

  • Gender (male/female; n): 23/15


H2 receptor antagonists
  • Age (years; mean (range)): 72 (58‐79)

  • Number of participants at baseline (n): 41

  • Gender (male/female; n): 25/16


Inclusion criteria
  • Mechanically ventilated for longer than 48 hours


Exclusion criteria
  • Admission diagnosis of pneumonia or other acute inflammatory pulmonary disease

  • Severe sepsis/septic shock

  • Regular use of proton pump inhibitors or H2 receptor antagonists


Baseline imbalances: no significant difference (P > 0.05) between groups regarding demographics
Interventions Proton pump inhibitors
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: ‐

  • Concomitant medications: ‐

  • Intervention: ‐


H2 receptor antagonists
  • Dose (total/d): ‐

  • Duration of treatment (days): ‐

  • Route: ‐

  • Concomitant medications: ‐

  • Intervention: ‐


Adherence to treatment:
Duration of follow‐up:
Duration of trial:
Outcomes Outcomes reported in trial and used in review
  • Clinically important upper GI bleeding

  • VAP diagnosed by leucocytosis, increased PCT level, fever, purulent tracheal secretion, positive microbiological result of tracheal sample, and new/increased infiltrate on chest X‐ray


Outcomes sought but not reported in trial
  • Mortality

  • Duration of ICU stay

  • Duration of intubation

  • Blood transfusion

  • Adverse events of interventions


Outcomes reported in trial but not used in review
  • Nil

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"
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