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

This study is currently recruiting participants.
Verified January 2012 by First Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01516359
First received: January 16, 2012
Last updated: January 19, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition
Injury of Other and Multiple Parts of Small Intestine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Official Title is Required by the WHO and ICMJE

Further study details as provided by First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • score of gut dysfunction [ Time Frame: eight months ] [ Designated as safety issue: No ]
    At different time points, gut dysfunction is graded according to previous criterion.


Secondary Outcome Measures:
  • The duration of cardiopulmonary bypass [ Time Frame: Eight months ] [ Designated as safety issue: No ]
    Record the duration of cardiopulmonary bypass

  • The duration for aortic artery clamping [ Time Frame: eight months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood samples are retained for the detections of some biomarkers and gene polymorphism.


Estimated Enrollment: 1000
Study Start Date: October 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with cardiac surgery

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.

  Eligibility

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing heart valve replacements under cardiopulmonary bypass

Criteria

Inclusion Criteria:

  • Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

  • Patients who die during or after operation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516359

Contacts
Contact: Ke Xuan Liu, MD,Ph.D. 86-20-87755766 ext 8273 liukexuan807@yahoo.com.cn

Locations
China, Guangdong
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ke Xuan Liu, MD, Ph.D.     86-13710684096     liukexuan807@yahoo.com.cn    
Contact: Cai Li, MD     86-18602017796     licaigz@yahoo.com.cn    
Principal Investigator: Ke Xuan Liu, MD, Ph.D.            
Sponsors and Collaborators
Cai Li
Investigators
Principal Investigator: Ke Xuan Liu, MD, Ph.D First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Cai Li, Vice head of Dept. of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01516359     History of Changes
Other Study ID Numbers: intestinal injury
Study First Received: January 16, 2012
Last Updated: January 19, 2012
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013