Gastric pH in Critically Ill Patients

December 26, 2007 updated by: Medical University of Vienna

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
patients with indication for stress ulcer prophylaxis and gastric pH < 4
Drug: esomeprazole
40mg once daily
Active Comparator: 2
patients with indication for stress ulcer prophylaxis and gastric pH < 4
Drug: ranitidine
50mg every h hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the percentage of time with gastric pH > 4
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
median gastric pH
Time Frame: 72 hours
72 hours
incidence of gastrointestinal bleeding
Time Frame: 72 hours
72 hours
incidence of ventilator associated pneumonia
Time Frame: ICU stay
ICU stay
the percentage of time with an gastric pH > 5
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Christian Madl, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

June 1, 2006

Study Registration Dates

First Submitted

December 26, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 11, 2008

Study Record Updates

Last Update Posted (Estimate)

January 11, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13H1-CM1
  • ESORAN trail

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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