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Gastric pH in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT00590928
Recruitment Status : Completed
First Posted : January 11, 2008
Last Update Posted : January 11, 2008
Information provided by:
Medical University of Vienna

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.

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

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  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : July 2004
Primary Completion Date : June 2006
Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. the percentage of time with gastric pH > 4 [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. median gastric pH [ Time Frame: 72 hours ]
  2. incidence of gastrointestinal bleeding [ Time Frame: 72 hours ]
  3. incidence of ventilator associated pneumonia [ Time Frame: ICU stay ]
  4. the percentage of time with an gastric pH > 5 [ Time Frame: 72 hours ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • gastrointestinal bleeding
  • gastric pH > 4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590928

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

Responsible Party: Christian Madl, MD, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00590928     History of Changes
Other Study ID Numbers: 13H1-CM1
ESORAN trail
First Posted: January 11, 2008    Key Record Dates
Last Update Posted: January 11, 2008
Last Verified: December 2007

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