MedPath

Gastric pH in Critically Ill Patients

Phase 4
Completed
Conditions
Critically Ill Patients
Indication for Stress Ulcer Prophylaxis
Interventions
Registration Number
NCT00590928
Lead Sponsor
Medical University of Vienna
Brief Summary

H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.

Detailed Description

Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
Inclusion Criteria
  • critically ill patients
  • indication for stress ulcer prophylaxis
  • gastric pH < 4
Exclusion Criteria
  • gastrointestinal bleeding
  • gastric pH > 4

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
1esomeprazolepatients with indication for stress ulcer prophylaxis and gastric pH \< 4
2ranitidinepatients with indication for stress ulcer prophylaxis and gastric pH \< 4
Primary Outcome Measures
NameTimeMethod
the percentage of time with gastric pH > 472 hours
Secondary Outcome Measures
NameTimeMethod
median gastric pH72 hours
incidence of gastrointestinal bleeding72 hours
incidence of ventilator associated pneumoniaICU stay
the percentage of time with an gastric pH > 572 hours

Trial Locations

Locations (1)

Medical University of Vienna, Department of Medicine III, ICU

🇦🇹

Vienna, Austria

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