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

Bashar 2013.

Methods Double‐blind parallel‐group randomised controlled trial
Participants Baseline characteristics
Number randomised: 146 participants
Number analysed: 120 participants
Ranitidine
  • Age (years; mean (SD)): 50.63 (20.78)

  • Number of participants (n): 60

  • Gender (male/female; n): 16/44


Pantoprazole
  • Age (years; mean (SD)): 43.67 (19.58)

  • Number of participants (n): 60

  • Gender (male/female; n): 18/42


Inclusion criteria
  • Intubated patients

  • Age > 18 years

  • Acute Physiology and Chronic Health Evaluation score (APACHE II) < 25


Exclusion criteria
  • Pneumonia

  • GI bleeding upon ICU admission

  • History of gastrectomy

  • Anticipated need for tracheal intubation in less than 48 hours

  • Known sensitivity to the studied medication


Baseline imbalances: We found no statistically significant differences between the 2 groups regarding baseline characteristics, such as age, sex, or APACHE II
Interventions Ranitidine
  • Dose (total/d): 150 mg IV or 300 mg PO

  • Duration of treatment (days): during NPO time or when oral feeding started

  • Route: IV or PO

  • Duration of follow‐up (days, mean (SD)): 15.67 (7.11)

  • Intervention: following admission to the ICU, 50 mg intravenous ranitidine (ranitidine 50 mg, Caspian Tamin Co., Rasht, Iran) was administered 3 times daily to 1 group of participants during NPO time to prevent stress ulcers. Thereafter, the day after oral feeding initiation, 150 mg oral ranitidine tablets (ranitidine 150 mg, Darou Pakhsh, Tehran, Iran) were administered twice daily until the end of the trialT

  • Concomitant medications: GI prophylaxis continued until ICU discharge. Other treatments were similarly administered to both groups according to the ICU protocol


Pantoprazole
  • Dose (total/d): 40 mg IV or 40 mg PO

  • Duration of treatment (days): during NPO time or when oral feeding started

  • Route: IV or PO

  • Duration of follow‐up (days): 17.58 (7.90) (until discharge)

  • Intervention: Second group received 40 mg intravenous pantoprazole (Pepticare 40 mg, Ronak Pharmaceutical Co., Saveh, Iran) once daily during NPO time. The day after oral feeding initiation, it was replaced with 40 mg pantoprazole tablets (E.C. Tablet Pantoprazole 40 mg, Osveh, Tehran, Iran) once a day for stress ulcer prophylaxis until the end of the trial

  • Concomitant medications: GI prophylaxis was continued until ICU discharge. Other treatments were similarly administered to both groups according to the ICU protocol


Adherence to regimen:
Duration of trial: July 2011 to July 2012
Duration of follow‐up:
Outcomes Outcomes sought in review and reported in trial
  • All‐cause mortality in ICU

  • Duration of intubation


Outcomes sought in review but not reported in trial
  • Clinically important GI bleeding

  • VAP

  • All‐cause mortality in hospital

  • Duration of ICU stay

  • Number of participants requiring blood transfusion

  • Number of units of blood transfused

  • Adverse events


Outcomes reported, but not used in the review
  • Days until VAP incidence

Notes Setting: ICU, Iran
Source of funding:
Conflicts of interest:
Ethics approval: Trial was approved by the Ethics Committee of Hamedan University of Medical Sciences.
Informed consent: Written informed consent was obtained from legal guardians of participants
Clinical trials registration:
Sample size calculation:
Conflicts of interest:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The patients were randomised using online random allocation software (www.allocationsoftware.com)"
Allocation concealment (selection bias) Unclear risk Comment: not enough information reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The patients and the attending intensivists responsible for data collection were blinded to the assigned groups"
Blinding (detection bias) 
 Clinically important upper GI bleeding Unclear risk Comment: Trial did not address this outcome
Blinding (detection bias) 
 Nosocomial pneumonia Low risk Quote: "Patients underwent chest radiography which was repeated at least twice a week"
Comment: Objective outcome measurement unlikely to introduce bias
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Low risk Quote: "The patients and intensivists responsible for data collection were blinded to the assigned groups"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All participants were followed up until discharge
Selective reporting (reporting bias) Low risk Comment: All outcomes listed in the Methods section were reported in the Results section
Other bias Low risk Comment: no other sources of bias suspected