Gastric pH in Critically Ill Patients

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00590928
First received: December 26, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted

December 26, 2007
December 26, 2007
July 2004
June 2006   (final data collection date for primary outcome measure)
the percentage of time with gastric pH > 4 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
  • median gastric pH [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • incidence of gastrointestinal bleeding [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
  • incidence of ventilator associated pneumonia [ Time Frame: ICU stay ] [ Designated as safety issue: Yes ]
  • the percentage of time with an gastric pH > 5 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Gastric pH in Critically Ill Patients
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.

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

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Critically Ill Patients
  • Indication for Stress Ulcer Prophylaxis
  • Drug: esomeprazole
    40mg once daily
  • Drug: ranitidine
    50mg every h hours
  • Active Comparator: 1
    patients with indication for stress ulcer prophylaxis and gastric pH < 4
    Intervention: Drug: esomeprazole
  • Active Comparator: 2
    patients with indication for stress ulcer prophylaxis and gastric pH < 4
    Intervention: Drug: ranitidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
June 2006
June 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00590928
13H1-CM1, ESORAN trail
No
Christian Madl, MD, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Christian Madl, MD Medical University of Vienna
Medical University of Vienna
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP