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Gastric pH in Critically Ill Patients

Primary Purpose

Critically Ill Patients, Indication for Stress Ulcer Prophylaxis

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
esomeprazole
ranitidine
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

the percentage of time with gastric pH > 4

Secondary Outcome Measures

median gastric pH
incidence of gastrointestinal bleeding
incidence of ventilator associated pneumonia
the percentage of time with an gastric pH > 5

Full Information

First Posted
December 26, 2007
Last Updated
December 26, 2007
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT00590928
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients, Indication for Stress Ulcer Prophylaxis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
patients with indication for stress ulcer prophylaxis and gastric pH < 4
Arm Title
2
Arm Type
Active Comparator
Arm Description
patients with indication for stress ulcer prophylaxis and gastric pH < 4
Intervention Type
Drug
Intervention Name(s)
esomeprazole
Intervention Description
40mg once daily
Intervention Type
Drug
Intervention Name(s)
ranitidine
Intervention Description
50mg every h hours
Primary Outcome Measure Information:
Title
the percentage of time with gastric pH > 4
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
median gastric pH
Time Frame
72 hours
Title
incidence of gastrointestinal bleeding
Time Frame
72 hours
Title
incidence of ventilator associated pneumonia
Time Frame
ICU stay
Title
the percentage of time with an gastric pH > 5
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: critically ill patients indication for stress ulcer prophylaxis gastric pH < 4 Exclusion Criteria: gastrointestinal bleeding gastric pH > 4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Madl, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna, Department of Medicine III, ICU
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Gastric pH in Critically Ill Patients

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