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

NCT ID: NCT00708149

Last Updated: 2013-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

lansprazole 30 mg qd from NG route or orally

Group Type ACTIVE_COMPARATOR

lansoprazole OD

Intervention Type DRUG

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

2

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

takepron placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lansoprazole OD

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

Intervention Type DRUG

placebo

takepron placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Takepron OD for PO QD

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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。
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chu C Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Far Eastern Memorial Hospital

Taipei, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 8284001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15483408 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9934901 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9339962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8930427 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CCLin

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.