Gastric pH in Critically Ill Patients

Critically Ill Patients Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00590928
• Other study ID #: 13H1-CM1
• Secondary ID: ESORAN trail
• Status: Completed
• Phase: Phase 4
• First received: December 26, 2007
• Last updated: December 26, 2007
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: December 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• critically ill patients

• indication for stress ulcer prophylaxis

• gastric pH < 4

Exclusion Criteria:

• gastrointestinal bleeding

• gastric pH > 4

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Critically Ill Patients
• Indication for Stress Ulcer Prophylaxis

Intervention

Drug:
• esomeprazole
40mg once daily
• ranitidine
50mg every h hours

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Medicine III, ICU	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the percentage of time with gastric pH > 4		72 hours	Yes
Secondary	median gastric pH		72 hours	Yes
Secondary	incidence of gastrointestinal bleeding		72 hours	Yes
Secondary	incidence of ventilator associated pneumonia		ICU stay	Yes
Secondary	the percentage of time with an gastric pH > 5		72 hours	Yes