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Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer

Information source: Emory University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stomach Ulcer

Intervention: Prevacid (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Emory University

Official(s) and/or principal investigator(s):
Qiang Cai, MD, PhD, Principal Investigator, Affiliation: Emory University
Vincent W Yang, MD, PhD, Study Director, Affiliation: Emory University

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.

Clinical Details

Official title: Effect of Prevacid on Prostaglandin Levels in the Gastric Mucosa of Patients With Stress Ulcer

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: the effect of Prevacid on prostaglandin levels at 8 weeks

Secondary outcome: esophagogastroduodenal endoscopy(EGD) with biopsy at day 1; EGD with biopsy at 8 weeks

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Emory University School of Medicine, Atlanta, Georgia 30322, United States
Additional Information

Starting date: October 2005
Last updated: July 29, 2013

Page last updated: August 23, 2015

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