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

Stoehr 2006.

Methods Randomised controlled trial
Participants Baseline characteristics
Number randomised: 30 participants
Number analysed: 30 participants
Sucralfate
  • Age (years; mean (SD)): ‐ (‐)

  • Number of participants (n): 15

  • Gender (male/female; n): 7/8


Ranitidine
  • Age (years; mean (SD)): ‐ (‐)

  • Number of participants (n): 15

  • Gender (male/female; n): 8/6


Inclusion criteria
  • Intact renal function

  • Requiring intensive care management and mechanical ventilation

  • Showing significantly increased risk of stress ulcer complications


Exclusion criteria
  • Age < 18 years

  • Pregnancy

  • Previous duodenal or gastric surgery

  • History of gastric ulcers, active upper gastrointestinal bleeding, or pneumonia; therapy with H2 receptor antagonists, antacids, omeprazole, pirenzepine, or sucralfate within the last year

  • Treatment with non‐steroidal anti‐inflammatory drugs or coumarin within the last 7 days

  • Primary coagulation disorders

  • Ventilation expected to last less than 3 days


Baseline characteristics: Quote: "The study sample was homogeneous in terms of age and sex distribution, duration of treatment, severity of illness, inclusion criteria, and basic intensive care regimens"
Interventions Sucralfate
  • Dose (total/d): 6 g

  • Duration of treatment (days): ‐

  • Route: IG tube

  • Intervention: 1 g 6 times daily by stomach tube

  • Concomitant medications: Enteral feeding was given to 50 participants


Ranitidine
  • Dose (total/d): 200 mg

  • Duration of treatment (days): ‐

  • Route: IV

  • Intervention: ranitidine (200 mg/d) by continuous intravenous infusion


Adherence to regimen:
Duration of trial:
Duration of follow‐up:
Outcomes Outcomes sought in review and reported in trial

Outcomes sought but not reported in trial
  • Upper GI bleeding

  • VAP

  • All‐cause mortality in hospital

  • Duration of ICU stay

  • Duration of intubation

  • Participants requiring blood transfusions

  • Units of blood transfused


Outcomes reported but not used in review
  • Aluminium content in nutrition solution

  • Aluminium intake

  • Serum aluminium levels

  • Renal aluminium excretion

Notes Setting: Surgical ICUs at a university hospital in Germany
Source of funding:
Ethics approval: Quote: "The study was approved by the Ethics Committee of the University of Düsseldorf"
Informed consent:
Clinical trials registration:
Sample size calculation:
Additonal notes:
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: no information reported
Allocation concealment (selection bias) Unclear risk Comment: no information reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Comment: no information reported
Blinding (detection bias) 
 Clinically important upper GI bleeding Unclear risk Comment: no information reported
Blinding (detection bias) 
 Nosocomial pneumonia Unclear risk Comment: This was not an outcome of the study
Blinding of outcome assessment (detection bias) 
 Adverse reactions of interventions Unclear risk Comment: This was not an outcome of the study
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Comment: All participants randomised were included in the analysis
Selective reporting (reporting bias) Low risk Comment: All outcomes described in the Methods section were included in the Results section
Other bias Low risk Comment: no other source of bias suspected. Source of funding unclear