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

Tabeefar 2012.

Methods Parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 27 participants
Number analysed: 27 participants
Pantoprazole I
  • Age (years; mean (SD)): 47.0 (11.0)

  • Number of participants (n): 11

  • Gender (male/female; n): 9/2


Pantoprazole II
  • Age (years, mean (SD)): 39.7 (8.0)

  • Number of participants (n): 8

  • Gender (male/female; n): 6/2


Ranitidine
  • Age (years, mean (SD)): 50.4 (8.0)

  • Number of participants (n): 8

  • Gender (male/female; n): 6/2


Inclusion criteria
  • Non per oral patients

  • Need of mechanical ventilation

  • Presence of a nasogastric tube with a gastric position confirmed on abdominal radiography

  • Baseline gastric juice with pH equal to or lower than 3.0

  • Presence of at least 1 risk factor other than ventilation for a gastroduodenal stress ulcer that would commonly indicate the SRMD prophylaxis

  • Not receiving any H2‐blocker, proton pump inhibitor, or antacids for the last 2 days

  • No enteral feeding during the study period


Exclusion criteria
  • Age < 18 years

  • Patients with renal or hepatic failure


Baseline imbalances: No statistical differences in age, sex, and basal pH and SOFA were found between treatment groups
Interventions Pantoprazole I
  • Dose (total/d): 80 mg

  • Duration of treatment (days): 2

  • Route: IV

  • Intervention: 40 mg every 12 hours for 48 hours (four doses)

  • Concomitant medications: none


Pantoprazole II
  • Dose (total/d): 80 mg

  • Duration of treatment (days): 2

  • Route: IV

  • Intervention: 80 mg/day pantoprazole as continuous infusion for 48 hours

  • Concomitant medications: none


Ranitidine
  • Dose (total/d): 150 mg

  • Duration of treatment (days): 2

  • Route: IV

  • Intervention: 150 mg ranitidine as 24 h continuous infusion for 48 hours

  • Concomitant medications: none


Adherence to regimen:
Duration of trial: April 2010 to August 2011
Duration of follow‐up: 2 days
Outcomes Outcomes sought in review and reported in trial

Outcomes sought but not reported in trial
  • Incidence of clinically important GI bleedingIncidence of VAP

  • Duration of ICU stay

  • All‐cause mortality in hospital

  • Duration of intubation

  • Adverse events of interventions


Outcomes reported in trial but not used in review
  • Plasma IL‐1 β concentration

  • Intragastric pH

Notes Setting: ICU, Department of Pharmacotherapy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran
Source of funding:
Conflicts of interest:
Ethics approval: Study protocol was approved by our institutional ethics committee
Informed consent: Written consent form was obtained from each patient’s closest family member
Clinical trials registration: This trial is registered in www.anzctr.org.au
Sample size calculation:
Additional notes:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly assigned to 3 study groups according to a computer‐generated table of random numbers"
Allocation concealment (selection bias) Unclear risk Comment: not enough information reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Comment: insufficient information to allow judgement, but the outcome is unlikely to be influenced by performance bias
Blinding (detection bias) 
 Clinically important upper GI bleeding Unclear risk Comment: Study did not address this outcome
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: Study did not address this outcome
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Low risk Comment: insufficient information to allow judgement, but the outcome is unlikely to be influenced by detection bias, provided it was a laboratory measurement.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: no incomplete outcome data suspected. All patients randomised at baseline were also included in the analyses
Selective reporting (reporting bias) Low risk Comment: All outcomes listed in the Methods section were also reported in the Results
Other bias Low risk Comment: no other sources of bias suspected