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

Noseworthy 1987.

Methods Open‐label randomised controlled trial
Participants Baseline characteristics
Number randomised: 86 participants
Number analysed: 86 participants
Ranitidine
  • Age (years; mean (SD)): 50 (20)

  • Number of participants (n): 42

  • Gender (male/female; n): 31/11


Antacids
  • Age (years; mean (SD)): 57 (21)

  • Number of participants (n): 44

  • Gender (male/female; n): 32/12


Inclusion criteria
  • Adult ICU patients


Exclusion criteria
  • Patients with active duodenal or gastric ulcers

  • Patients diagnosed with GI bleeding during admission

  • Patients on antacids or H2 receptor antagonists within the previous 12 hours


Baseline imbalances: Groups were similar with respect to age, gender, and admission diagnosis. Acute and chronic respiratory failure were the most common causes for admission
Interventions Ranitidine
  • Dose (total/d): 200 mg

  • Duration of treatment (days): 23 of 42 participants continued up to 72 hours

  • Route: IV

  • Intervention: 50 mg IV every 6 hours or 75 mg IV every 6 hours if gastric pH not maintained at or above 4 for at least 50% of hourly observations during 6‐hour interval between doses

  • Concomitant medications: Corticosteroids and heparin were given to 1 participant


Antacids
  • Dose (total/d): 720 mL

  • Duration of treatment (days): 25 participants of the 44 continued up to 72 hours

  • Route: NG tube

  • Intervention: antacids (Maalox n = 42 and Amphogel n = 3) (TC magnesium hydroxide, aluminium hydroxide) 30 mL/hour via NG tube

  • Concomitant medications: Corticosteroids and heparin were given to 1 participant


Adherence to regimen: Quote: "Eightysix patients were randomised, 42 received ranitidine, 44 received antacids (malox: 42 and amphojel:3), 38 receiving ranitidine completed 48 hours of study while 23 continued up to 72 hours. Of the patients receiving antacids, 39 completed 48 hours of study, while 25 continued up to 76 hours"
Duration of trial:
Duration of follow‐up:
Outcomes Outcomes sought in review and reported in trial
  • Incidence of upper GI bleeding

  • All‐cause mortality in ICU

  • Adverse events of interventions


Outcomes sought but not reported in trial
  • Incidence of ventilator associated pneumonia

  • All‐cause mortality in hospital

  • Duration of ICU stay

  • Duration of intubation

  • Participants requiring blood transfusions

  • Units of blood transfused


Outcomes reported in trial but not used in review
  • Intragastric pH status (with and without enteral nutrition)

  • Creatinine levels and its subsequent clearance

Notes Setting: Department of Adult Intensive Care, Royal Alexandria Hospitals, Edmonton, and the Division of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada
Source of funding:
Conflicts of interest:
Ethics approval:
Clinical trials registration:
Sample size calculation:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Using a computer generated table of numbers, patients were assigned by restricted randomisation...”
 Comment: Method adopted to obtain random sequence generation is clearly mentioned in the study report
Allocation concealment (selection bias) Low risk Comment: not clearly mentioned in the study report
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: This was not a placebo‐controlled trial, and the different modes of administering study interventions would not have made it possible to blind study personnel and participants.Therefore, high risk of performance bias
Blinding (detection bias) 
 Clinically important upper GI bleeding High risk Comment: There was no clear definition for detecting clinically significant upper GI bleeding, and it is unclear whether the unblinded nature of the study influenced this outcome, which was otherwise objective in nature
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: All other outcomes of interest were objective in nature. Therefore the likelihood of detection bias is low
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: Although 1 participant withdrew from each group during the course of the study, all randomised participants were part of the final analysis.Therefore there was no attrition bias
Selective reporting (reporting bias) Low risk Comment: All intended outcomes have been reported
Other bias Low risk Comment: no mention of the source of funding. No additional biases were detected