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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Cai Li, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01516359
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cai Li, First Affiliated Hospital, Sun Yat-Sen University
  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 Cai Li, First Affiliated Hospital, Sun Yat-Sen University:

Primary Outcome Measures:
  • score of gut dysfunction [ Time Frame: eight months ]
    At different time points, gut dysfunction is graded according to previous criterion.


Secondary Outcome Measures:
  • The duration of cardiopulmonary bypass [ Time Frame: Eight months ]
    Record the duration of cardiopulmonary bypass

  • The duration for aortic artery clamping [ Time Frame: eight months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 16, 2012
First Posted: January 24, 2012
Last Update Posted: January 24, 2012
Last Verified: January 2012