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The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery

NCT ID: NCT01479049

Last Updated: 2011-11-24

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.

Detailed Description

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Conditions

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Congenital Heart Disease

Keywords

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congenital heart disease cardiac surgery cardiopulmonary bypass cardioplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MP group

Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.

Group Type EXPERIMENTAL

MP (moderate potassium) group

Intervention Type DRUG

Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation

HP group

Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation

Group Type ACTIVE_COMPARATOR

HP (High potassium) group

Intervention Type DRUG

Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.

Interventions

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MP (moderate potassium) group

Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation

Intervention Type DRUG

HP (High potassium) group

Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.

Intervention Type DRUG

Other Intervention Names

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moderate potassium cardioplegia High potassium cardioplegia

Eligibility Criteria

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Inclusion Criteria

* pediatric patients (body weight\<10 kg)
* congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.

Exclusion Criteria

* other systemic diseases
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenxiao Jin, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery, Xijing Hospital

Locations

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Department of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Countries

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China

Other Identifiers

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XJXZ2009-1010

Identifier Type: -

Identifier Source: org_study_id