NCT01516359

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

January 16, 2012

Last Update Submit

January 19, 2012

Conditions

Injury of Other and Multiple Parts of Small Intestine

Outcome Measures

Primary Outcomes (1)

  • score of gut dysfunction

    At different time points, gut dysfunction is graded according to previous criterion.

    eight months

Secondary Outcomes (2)

  • The duration of cardiopulmonary bypass

    Eight months

  • The duration for aortic artery clamping

    eight months

Study Arms (1)

patients with cardiac surgery

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing heart valve replacements under cardiopulmonary bypass

You may qualify if:

  • Patients undergoing heart valve replacements under cardiopulmonary bypass

You may not qualify if:

  • Patients who die during or after operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Officials

  • Ke Xuan Liu, MD, Ph.D

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke Xuan Liu, MD,Ph.D.

CONTACT

86-20-87755766liukexuan807@yahoo.com.cn

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice head of Dept. of Anesthesiology

Study Record Dates

First Submitted

January 16, 2012

First Posted

January 24, 2012

Study Start

October 1, 2011

Primary Completion

October 1, 2012

Study Completion

November 1, 2012

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

CN(1)