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

Respiratory Failure Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00708149
• Other study ID #: CCLin
• Status: Completed
• Phase: Phase 4
• First received: March 3, 2008
• Last updated: January 6, 2013
• Start date: June 2009
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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?

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Drug:
• lansoprazole OD
arm 1: lansprazole 30 mg qd from NG route or orally for 14 days
• placebo
takepron placebo

Locations

Country	Name	City	State
Taiwan	Far Eastern Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

Lam NP, Lê PD, Crawford SY, Patel S. National survey of stress ulcer prophylaxis. Crit Care Med. 1999 Jan;27(1):98-103. — View Citation

Tryba M, Cook D. Current guidelines on stress ulcer prophylaxis. Drugs. 1997 Oct;54(4):581-96. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	30 days mortality rate		30 days	Yes

External Links

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