Official Title: “Phase IV Study of Comparison of Lansoprazole OD and Placebo for Stress Ulcer Bleeding Prophylaxis in Patients Weaning From Ventilator in Respiratory Intensive Care Unit”

The purpose of this study is to determine whether lansoprazole administered nasogastrically is effective for stress ulcer prophylaxis in respiratory intensive care unit.

Study Type: Interventional

Study Design: Prevention, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2009

Although stress ulcer is a complication that can cause mortality and morbidity in critical patients, there is still lack of consensus about its prophylaxis. There is also few data available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less associated nosocomial pneumonia.

Recently, proton pump inhibitors were shown to have good prophylactic effects for stress ulcer. Lansoprazole has good acid suppression effect and the tablets are soluble for the use of tube feeding. There was no data about the prophylaxis of stress ulcer development during the program of weaning from the mechanical ventilators. Therefore, we conduct a study of the comparison of lansoprazole administered nasogastrically and control group for stress ulcer prophylaxis in respiratory intensive care unit.

Intervention(s) in this Clinical Trial

• Drug: lansoprazole OD
  • arm 1: lansprazole 30 mg qd from NG route or orally for 14 days
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • lansprazole 30 mg qd from NG route or orally
• Placebo Comparator: 2
  • control group without any PPI, H2 blockers or other medications for treating peptic ulcers.

Primary Measures

• Overt UGI bleeding: (1)tarry stool or coffee ground substance or fresh blood from NG≥ 60ml (2)blood component transfusion for more than PRBC 2 units 3)PES or TAE or surgical intervention for hemostasis
  • Time Frame: The first 30 days after RCC admission
    Safety Issue?: Yes

Secondary Measures

• 30 days mortality rate
  • Time Frame: 30 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Initial ICU admission, APACHE II score ≥25。
• 2. Evidence of IICP ( ICP monitor proved or brain CT proved edema)。
• 3. Evidence of peptic ulcer disease ( A or H) proved by PES more than 3 months ago without PPI or H2 blocker agents therapy in recent one week。
• 4. UGI bleeding history in ICU before transferring to RCC (proved by NG aspirate coffee ground substance or fresh blood ≥ 60 ml)。Not received PPI or H2 blocker agents in recent one week.
• 5. Received NSAID for more than 7 days。
• 6. Bleeding tendency or with major disease patients: coagulopathy, ESRD (CCR<10), hematologic malignancy, liver cirrhosis Child C。

Exclusion Criteria:

• 1. Age < 18 y/o, pregnancy。
• 2. Active UGI bleeding and under PPI or H2-blockers。
• 3. Family unwillings。

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Far Eastern Memorial Hospital

Overall Clinical Trial Officials and Contacts

Chu C Lin, MD Principal Investigator Far Eastern Memorial Hospital  

Overall Contact: Chu C Lin, MD 886-2-89667000 s0316@ms10.hinet.net

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00708149

Study ID Number: CCLin

ClinicalTrials.gov Identifier: NCT00708149

Health Authority: United States: Institutional Review Board