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Gastric pH in Critically Ill Patients

This study has been completed.
Study NCT00590928.   Last updated on December 26, 2007.   Information provided by Medical University of Vienna

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Descriptive Information Fields
Brief Title  Gastric pH in Critically Ill Patients
Official Title  Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.
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.

Study Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Primary Outcome Measure  the percentage of time with gastric pH > 4 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  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 ]
Condition  Critically Ill Patients
Indication for Stress Ulcer Prophylaxis
Intervention  Drug: esomeprazole
Drug: ranitidine
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  75
Start Date  July 2004
Completion Date June 2006
Eligibility Criteria 

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4
Gender Both
Ages 18 Years to 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Austria
Administrative Information Fields
NCT ID  NCT00590928
Organization ID 13H1-CM1
Secondary IDs †† ESORAN trail
Study Sponsor  Medical University of Vienna
Collaborators ††
Investigators 
Principal Investigator:     Christian Madl, MD     Medical University of Vienna    
Information Provided By Medical University of Vienna
Verification Date December 2007
First Received Date  December 26, 2007
Last Updated Date December 26, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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