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

January 19, 2012 updated by: Cai Li

Official Title is Required by the WHO and ICMJE

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ke Xuan Liu, MD, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing heart valve replacements under cardiopulmonary bypass

Description

Inclusion Criteria:

  • Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

  • Patients who die during or after operation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with cardiac surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score of gut dysfunction
Time Frame: eight months
At different time points, gut dysfunction is graded according to previous criterion.
eight months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The duration of cardiopulmonary bypass
Time Frame: Eight months
Record the duration of cardiopulmonary bypass
Eight months
The duration for aortic artery clamping
Time Frame: eight months
eight months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cai Li

Investigators

  • Principal Investigator: Ke Xuan Liu, MD, Ph.D, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

October 1, 2012

Study Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 24, 2012

Study Record Updates

Last Update Posted (Estimate)

January 24, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • intestinal injury

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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