Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

Phase 4

Completed

• Conditions: Stomach Ulcer
• Interventions: Drug: Prevacid

• Registration Number: NCT00239551
• Lead Sponsor: Emory University

Brief Summary

The purpose of this study is to measure the prostaglandin levels in patients with stress ulcer and the effect of Prevacid on prostaglandin levels in patients with stress ulcer.

Detailed Description

The prostaglandin system plays an important role in the gastric mucosa to strengthen its resistance against injury. Critically ill patients are at greatest risk of developing stress-related gastric mucosal lesions. Although the levels of prostaglandins in gastric mucosa in patients with stressed animal has been studied, prostaglandin levels in the gastric mucosa in patients with stress ulcer have not been studied and the effect of Prevacid on prostaglandin levels in gastric mucosa from patients with stress ulcer is unknown.

We hypothesize that prostaglandin levels are low in the gastric mucosa in patients with stress ulcer, and Prevacid is an effective agents in increasing prostaglandin levels in the gastric mucosa in stress stress ulcer.

Comparison(s): The prostaglandin levels in patients who treated with Prevacid for stress ulcer, compared to the prostaglandin levels in patients who treated with H2 blocker for stress ulcer.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-13
• Study First Submitted QC: 2005-10-13
• Study First Posted: 2005-10-17
• Primary Completion: 2006-10
• Study Completion: 2007-12
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients in ICU with documented gastric stress ulcer by endoscopic examination, including patients with H. Pylori infection;
• Patients have no known ulcer within 8 weeks prior to be admitted to ICU;
• Patients not on any PPI for 4 weeks prior to the study;
• Patients or family be consented for the study.

Exclusion Criteria

• Patients have gastric ulcer within 8 weeks prior to be admitted to ICU;
• Patients have gastric cancer confirmed by pathology;
• Patients on one of the PPIs already;
• Patients on any of the Non-steroidal Antiinflammatory Drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevacid	Prevacid	Effect of Prevacid at 8 weeks; EGD(esophagogastroduodenal endoscopy) at day 1 \& EGD at 8 weeks

Primary Outcome Measures

Name	Time	Method
the effect of Prevacid on prostaglandin levels at 8 weeks	8 weeks

Secondary Outcome Measures

Name	Time	Method
esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks	8 weeks

Trial Locations

Locations (1)

Emory University School of Medicine; 🇺🇸 Atlanta, Georgia, United States