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Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial

Primary Purpose

Respiratory Failure

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

lansoprazole OD

placebo

About this trial

This is an interventional prevention trial for Respiratory Failure focused on measuring lansoprazole, weaning,stress ulcer prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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。

Sites / Locations

Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

lansprazole 30 mg qd from NG route or orally

control group without any PPI, H2 blockers or other medications for treating peptic ulcers.

Outcomes

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

Secondary Outcome Measures

30 days mortality rate

Full Information

NCT ID

NCT00708149

First Posted

March 3, 2008

Last Updated

January 6, 2013

Sponsor

Far Eastern Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00708149

Brief Title

Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial

Official Title

Phase IV Study of Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Far Eastern Memorial Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

lansoprazole, weaning,stress ulcer prophylaxis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

lansprazole 30 mg qd from NG route or orally

Arm Title

Arm Type

Placebo Comparator

Arm Description

control group without any PPI, H2 blockers or other medications for treating peptic ulcers.

Intervention Type

Drug

Intervention Name(s)

lansoprazole OD

Other Intervention Name(s)

Takepron OD for PO QD

Intervention Description

arm 1: lansprazole 30 mg qd from NG route or orally for 14 days

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

takepron placebo

Primary Outcome Measure Information:

Title

Time Frame

The first 30 days after RCC admission

Secondary Outcome Measure Information:

Title

30 days mortality rate

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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。

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chu C Lin, MD

Organizational Affiliation

Far Eastern Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Far Eastern Memorial Hospital

City

Taipei

ZIP/Postal Code

22050

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

8284001

Citation

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. doi: 10.1056/NEJM199402103300601.

Results Reference

background

PubMed Identifier

15483408

Citation

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. doi: 10.1097/01.ccm.0000142398.73762.20.

Results Reference

background

PubMed Identifier

9934901

Citation

Lam NP, Le PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103. doi: 10.1097/00003246-199901000-00034.

Results Reference

background

PubMed Identifier

9339962

Citation

Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. doi: 10.2165/00003495-199754040-00005.

Results Reference

background

PubMed Identifier

8930427

Citation

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. doi: 10.1016/s0149-2918(96)80043-9.

Results Reference

background

Links:

URL

http://www.e-pharm.info/index.php?option=com_content&view=category&id=38&Itemid=103

Description

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