CompletedPhase 4

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

Taiwan120 participantsStarted 2009-06

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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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。

What they're measuring

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

Timeframe: The first 30 days after RCC admission

Trial details

NCT IDNCT00708149

SponsorFar Eastern Memorial Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-02

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