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

NCT ID: NCT01398709

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-09-30

Brief Summary

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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

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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).

Conditions

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Cardiac Surgery Cardiopulmonary Bypass Rewarming Rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Slow rewarming strategy

Slow rewarming strategy (0.24 degrees C/min)

Group Type ACTIVE_COMPARATOR

Slow rewarming strategy

Intervention Type OTHER

Rewarming rate:0.24 degrees C/min.

Fast rewarming strategy

Fast rewarming strategy (0.5 degrees C/min)

Group Type ACTIVE_COMPARATOR

Fast rewarming strategy

Intervention Type OTHER

Rewarming rate:0.5 degrees C/min.

Interventions

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Slow rewarming strategy

Rewarming rate:0.24 degrees C/min.

Intervention Type OTHER

Fast rewarming strategy

Rewarming rate:0.5 degrees C/min.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital

Principal Investigators

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Dinghua Yi, MD

Role: STUDY_CHAIR

Xijing Hospital

Locations

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Xijing Hospital

Xi'an, Shannxi, China

Site Status

Countries

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China

Central Contacts

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Chunhu Gu, MD

Role: CONTACT

Facility Contacts

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Chunhu Gu, MD

Role: primary

Other Identifiers

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Guch-011

Identifier Type: -

Identifier Source: org_study_id

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