Gastric pH in Critically Ill Patients

Medical University of Vienna

Status and phase: Completed; Phase 4

Conditions: Indication for Stress Ulcer Prophylaxis; Critically Ill Patients

Treatments: Drug: esomeprazole; Drug: ranitidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00590928

13H1-CM1

ESORAN trail

Details and patient eligibility

About

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.

Full description

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

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• gastrointestinal bleeding
• gastric pH > 4

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: esomeprazole

2

Active Comparator group

Description:

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

Treatment:

Drug: ranitidine