Effect of Rewarming Rate During Cardiopulmonary Bypass on... | NCT01398709

Studies
Effect of Rewarming Rate During Cardiopulmonary Bypass on Clinical Prognosis of Infants Undergoing Cardiac Surgery

NCT01398709

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Jul 20, 2011Estimated

Enrollment

100Estimated

Phase

Phase 2

Conditions

Cardiac Surgery
Cardiopulmonary Bypass
Rewarming Rate

Interventions

Slow rewarming strategy
Fast rewarming strategy

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

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Sep 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 20, 2011Estimated

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

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

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 relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in infants undergoing cardiac surgery.

Detailed Description

There have been many studies indicating that rewarming management plays an important role in cardiac surgery. The purpose of this study is to investigate the relationship between rewarming rate during cardiopulmonary bypass and clinical prognosis in patients undergoing cardiac surgery. Infants undergoing cardiac surgery with cardiopulmonary bypass are randomly assigned to either a slow rewarming strategy (0.24 degrees C/min) or a fast rewarming strategy (0.5 degrees C/min).

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Slow rewarming strategy	Active Comparator	Slow rewarming strategy (0.24 degrees C/min)	Other: Slow rewarming strategy
Fast rewarming strategy	Active Comparator	Fast rewarming strategy (0.5 degrees C/min)	Other: Fast rewarming strategy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Slow rewarming strategy	Other	Rewarming rate:0.24 degrees C/min.	Slow rewarming strategy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause mortality		one year

Secondary Outcomes

Measure	Description	Time Frame
Acute renal failure		one month
Respiratory failure		one month
ICU and hospital length of stay, and ICU readmissions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants who had underwent cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

Preoperative liver or kidney disease or dysfunction
Preoperative coagulation disorder
Palliative operation or a second operation
Above 3 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chunhu Gu, MD	Contact			guchunhu@fmmu.edu.cn

Overall Officials

Name	Affiliation	Role
Dinghua Yi, MD	Xijing Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital		Xi'an	Shannxi	710032	China