NCT00708149

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2008

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 2, 2008

Completed
11 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

January 8, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

March 3, 2008

Last Update Submit

January 6, 2013

Conditions

Respiratory Failure

Keywords

lansoprazole, weaning,stress ulcer prophylaxis

Outcome Measures

Primary Outcomes (1)

  • 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

    The first 30 days after RCC admission

Secondary Outcomes (1)

  • 30 days mortality rate

    30 days

Study Arms (2)

1

ACTIVE COMPARATOR

lansprazole 30 mg qd from NG route or orally

Drug: lansoprazole OD

2

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

lansoprazole ODDRUG

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

Also known as: Takepron OD for PO QD
1
placeboDRUG

takepron placebo

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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。

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 22050, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 8284001BACKGROUND

  • 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.

    PMID: 15483408BACKGROUND

  • 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.

    PMID: 9934901BACKGROUND

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

    PMID: 9339962BACKGROUND

  • 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.

    PMID: 8930427BACKGROUND

Related Links

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Chu C Lin, MD

    Far Eastern Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

July 2, 2008

Study Start

June 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

January 8, 2013

Record last verified: 2013-01

Locations

TW(1)