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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was  Recruiting
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
  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
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, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014