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Completed

NCT Number: NCT00708149

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Far Eastern Memorial Hospital

Taipei, 22050, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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。

Treatment and study plan

lansoprazole OD

Drug

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

Other names: Takepron OD for PO QD

Placebo

Drug

takepron placebo

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

    Time frame: The first 30 days after RCC admission

Secondary outcomes

  1. 30 days mortality rate

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 2, 2008
Registry last updated
Jan 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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