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

Far Eastern Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Respiratory Failure

Treatments: Drug: placebo; Drug: lansoprazole OD

Study type: Interventional

Funder types: Other

Identifiers

NCT00708149

CCLin

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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。

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

lansprazole 30 mg qd from NG route or orally

Treatment:

Drug: lansoprazole OD

2

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo