Gastric pH in Critically Ill Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

December 26, 2007

Last Updated Date

December 26, 2007

Start Date ^ICMJE

July 2004

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

the percentage of time with gastric pH > 4 [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Gastric pH in Critically Ill Patients

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Critically Ill Patients
Indication for Stress Ulcer Prophylaxis

Intervention ^ICMJE

Drug: esomeprazole
Drug: ranitidine

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2006

Primary Completion Date

June 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Austria

Administrative Information

NCT ID ^ICMJE

NCT00590928

Responsible Party

Christian Madl, MD, Medical University of Vienna

Study ID Numbers ^ICMJE

13H1-CM1, ESORAN trail

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christian Madl, MD

Medical University of Vienna

Information Provided By

Medical University of Vienna

Verification Date

December 2007

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