Gastric pH in Critically Ill Patients

Condition(s) targeted: Critically Ill Patients; Indication for Stress Ulcer Prophylaxis

Intervention: esomeprazole (Drug); ranitidine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Medical University of Vienna

Official(s) and/or principal investigator(s):
Christian Madl, MD, Principal Investigator, Affiliation: Medical University of Vienna

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.

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

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

Primary outcome: the percentage of time with gastric pH > 4

Secondary outcome:

median gastric pH

incidence of gastrointestinal bleeding

incidence of ventilator associated pneumonia

the percentage of time with an gastric pH > 5

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

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- critically ill patients

- indication for stress ulcer prophylaxis

- gastric pH < 4

Exclusion Criteria:

- gastrointestinal bleeding

- gastric pH > 4

Medical University of Vienna, Department of Medicine III, ICU, Vienna 1090, Austria

Starting date: July 2004
Ending date: June 2006
Last updated: December 26, 2007