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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
  Purpose

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.


Condition Intervention Phase
Critically Ill Patients
Indication for Stress Ulcer Prophylaxis
 Drug: esomeprazole
Drug: ranitidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 75
Study Start Date: July 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590928

Locations
Austria
Medical University of Vienna, Department of Medicine III, ICU
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Madl, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Christian Madl, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00590928     History of Changes
Other Study ID Numbers: 13H1-CM1, ESORAN trail
Study First Received: December 26, 2007
Last Updated: December 26, 2007
Health Authority: Austria: Federal Ministry for Health and Women

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Omeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
 Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013