Comparison of Lansoprazole OD and Placebo for Stress Ulcer Bleeding Prophylaxis in Patients Weaning From Ventilator.

Condition(s) targeted: Respiratory Failure

Intervention: lansoprazole OD (Drug); placebo (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Far Eastern Memorial Hospital

Official(s) and/or principal investigator(s):
Chu C Lin, MD, Principal Investigator, Affiliation: Far Eastern Memorial Hospital

Overall contact:
Chu C Lin, MD, Phone: 886-2-89667000, Ext: 1704, Email: s0316@ms10.hinet.net

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

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

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

Primary outcome: 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

Secondary outcome: 30 days mortality rate

Detailed description: 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.

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

Criteria:

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。

Chu C Lin, MD, Phone: 886-2-89667000, Ext: 1704, Email: s0316@ms10.hinet.net

Far Eastern Memorial Hospital, Taipei 22050, Taiwan

Related publications:

Cook DJ, Fuller HD, Guyatt GH, Marshall JC, Leasa D, Hall R, Winton TL, Rutledge F, Todd TJ, Roy P, et al. Risk factors for gastrointestinal bleeding in critically ill patients. Canadian Critical Care Trials Group. N Engl J Med. 1994 Feb 10;330(6):377-81.

Daley RJ, Rebuck JA, Welage LS, Rogers FB. Prevention of stress ulceration: current trends in critical care. Crit Care Med. 2004 Oct;32(10):2008-13.

Lam NP, Lê PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103.

Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. Review.

Chun AH, Shi HH, Achari R, Dennis S, Cavanaugh JH. Lansoprazole: administration of the contents of a capsule dosage formulation through a nasogastric tube. Clin Ther. 1996 Sep-Oct;18(5):833-42.

Starting date: January 2009
Ending date: December 2009
Last updated: February 6, 2009