Official Title: “Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Study Primary Completion Date: June 2006

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

Intervention(s) in this Clinical Trial

• Drug: esomeprazole
  • 40mg once daily
• Drug: ranitidine
  • 50mg every h hours

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • patients with indication for stress ulcer prophylaxis and gastric pH < 4
• Active Comparator: 2
  • patients with indication for stress ulcer prophylaxis and gastric pH < 4

Primary Measures

• the percentage of time with gastric pH > 4
  • Time Frame: 72 hours
    Safety Issue?: Yes

Secondary Measures

• median gastric pH
  • Time Frame: 72 hours
    Safety Issue?: Yes
• incidence of gastrointestinal bleeding
  • Time Frame: 72 hours
    Safety Issue?: Yes
• incidence of ventilator associated pneumonia
  • Time Frame: ICU stay
    Safety Issue?: Yes
• the percentage of time with an gastric pH > 5
  • Time Frame: 72 hours
    Safety Issue?: Yes

Inclusion Criteria:

• critically ill patients
• indication for stress ulcer prophylaxis
• gastric pH < 4

Exclusion Criteria:

• gastrointestinal bleeding
• gastric pH > 4

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Medical University of Vienna

Overall Clinical Trial Officials and Contacts

Christian Madl, MD Principal Investigator Medical University of Vienna  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00590928

Study ID Number: 13H1-CM1

ClinicalTrials.gov Identifier: NCT00590928

Health Authority: Austria: Federal Ministry for Health and Women