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

Sponsor:	Far Eastern Memorial Hospital
Information provided by:	Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00708149

Purpose

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

Condition	Intervention	Phase
Respiratory Failure	Drug: lansoprazole OD Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: Lansoprazole

U.S. FDA Resources

Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

30 days mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	January 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 lansprazole 30 mg qd from NG route or orally	Drug: lansoprazole OD arm 1: lansprazole 30 mg qd from NG route or orally for 14 days Other Name: Takepron OD for PO QD
Placebo Comparator: 2 control group without any PPI, H2 blockers or other medications for treating peptic ulcers.	Drug: placebo takepron placebo

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Initial ICU admission, APACHE II score ≥25。
Evidence of IICP ( ICP monitor proved or brain CT proved edema)。
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。
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.
Received NSAID for more than 7 days。
Bleeding tendency or with major disease patients: coagulopathy, ESRD (CCR<10), hematologic malignancy, liver cirrhosis Child C。

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00708149

Contacts

Contact: Chu C Lin, MD	886-2-89667000 ext 1704	s0316@ms10.hinet.net
Contact: Hsi T Lee, MD	886-2-89667000 ext 1702	thleekimo@yahoo.com.tw

Locations

Taiwan
Far Eastern Memorial Hospital	Active, not recruiting
Taipei, Taiwan, 22050

Sponsors and Collaborators

Far Eastern Memorial Hospital

Investigators

Principal Investigator:

Chu C Lin, MD

Far Eastern Memorial Hospital

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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.

Responsible Party:	Chien Chu Lin, Department of Internal Medicine, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00708149 History of Changes
Other Study ID Numbers:	CCLin
Study First Received:	March 3, 2008
Last Updated:	February 6, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Far Eastern Memorial Hospital:

lansoprazole, weaning,stress ulcer prophylaxis

Additional relevant MeSH terms:

Hemorrhage
Ulcer
Respiratory Insufficiency
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Lansoprazole

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012