Status:

COMPLETED

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

Lead Sponsor:

Far Eastern Memorial Hospital

Conditions:

Respiratory Failure

Eligibility:

All Genders

18+ years

Phase:

PHASE4

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 Taiwa...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

June 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2012

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00708149

Start Date

June 1 2009

End Date

February 1 2012

Last Update

January 8 2013

Active Locations (1)

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1

Far Eastern Memorial Hospital

Taipei, Taiwan, 22050