Incidence and Predictive Factors of Intestinal Injury in... | NCT01516359

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

NCT01516359

Sponsor

Cai Li

Status

Unknown status

Last Update Posted

Jan 24, 2012Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Injury of Other and Multiple Parts of Small Intestine

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Oct 2012Estimated

Completion Date

Nov 2012Estimated

First Submitted Date

Jan 16, 2012

First Submission Date that Met QC Criteria

Jan 19, 2012

First Posted Date

Jan 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2012

Last Update Posted Date

Jan 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cai Li, Vice head of Dept. of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen UniversitySponsor-Investigator

Lead Sponsor

Cai LiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Estimated

Label	Type	Description	Intervention Names
patients with cardiac surgery

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing heart valve replacements under cardiopulmonary bypass

Exclusion Criteria:

Patients who die during or after operation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients undergoing heart valve replacements under cardiopulmonary bypass

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ke Xuan Liu, MD,Ph.D.	Contact	86-20-87755766	8273	liukexuan807@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
Ke Xuan Liu, MD, Ph.D	First Affiliated Hospital, Sun Yat-Sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510080	China