Gastric pH in Critically Ill Patients - Full Text View

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 IV

MedlinePlus related topics:

Stress

ChemIDplus related topics:

Ranitidine Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium Ranitidine Hydrochloride Ranitidine bismuth citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Official Title:	Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.

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
1: Active Comparator patients with indication for stress ulcer prophylaxis and gastric pH < 4	Drug: esomeprazole 40mg once daily
2: Active Comparator 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

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

Study placed in the following topic categories:

Bismuth tripotassium dicitrate

Ranitidine

Ranitidine bismuth citrate

Critical Illness

Ulcer

Citric Acid

Histamine phosphate

Omeprazole

Stress

Histamine

Bismuth

Additional relevant MeSH terms:

Disease Attributes

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Gastrointestinal Agents

Histamine Agents

Enzyme Inhibitors

Pharmacologic Actions

Histamine H2 Antagonists

Pathologic Processes

Histamine Antagonists

Therapeutic Uses

Anti-Ulcer Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00590928