Incidence and Predictive Factors of Intestinal Injury in Patients Undergoing Heart Valve Replacements

• Conditions: Injury of Other and Multiple Parts of Small Intestine

• Registration Number: NCT01516359
• Lead Sponsor: Cai Li

Brief Summary

The purpose of this study is to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement through a multicenter study in China.

Detailed Description

Intestinal injury is one of main reasons for mobidity and mortality after heart valve replacement, but its incidence and potential risk factors remain unclear. A multicenter study in China is undertaken to investigate the incidence and predictive factors related to intestinal injury in patients undergoing heart valve replacement.

Study Timeline

• Study Start: 2011-10
• Status Verified: 2012-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Last Update Submitted: 2012-01-19
• Study First Posted: 2012-01-24
• Last Update Posted: 2012-01-24
• Primary Completion: 2012-10
• Study Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria

• Patients who die during or after operation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
score of gut dysfunction	eight months	At different time points, gut dysfunction is graded according to previous criterion.

Secondary Outcome Measures

Name	Time	Method
The duration of cardiopulmonary bypass	Eight months	Record the duration of cardiopulmonary bypass
The duration for aortic artery clamping	eight months

Trial Locations

Locations (1)

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China