Back to resultsThe Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
Primary Purpose
Congenital Heart Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MP (moderate potassium) group
HP (High potassium) group
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring congenital heart disease, cardiac surgery, cardiopulmonary bypass, cardioplegia
Eligibility Criteria
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
Sites / Locations
- Department of Cardiovascular Surgery, Xijing Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MP group
HP group
Arm Description
Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.
Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation
Outcomes
Primary Outcome Measures
post-operative Serum cTnI concentration decreased significantly in 24hours
myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01479049
Brief Title
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
Official Title
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
congenital heart disease, cardiac surgery, cardiopulmonary bypass, cardioplegia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MP group
Arm Type
Experimental
Arm Description
Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.
Arm Title
HP group
Arm Type
Active Comparator
Arm Description
Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation
Intervention Type
Drug
Intervention Name(s)
MP (moderate potassium) group
Other Intervention Name(s)
moderate potassium cardioplegia
Intervention Description
Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation
Intervention Type
Drug
Intervention Name(s)
HP (High potassium) group
Other Intervention Name(s)
High potassium cardioplegia
Intervention Description
Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.
Primary Outcome Measure Information:
Title
post-operative Serum cTnI concentration decreased significantly in 24hours
Description
myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.
Time Frame
24h after myocardial reperfusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, PhD
Organizational Affiliation
Department of Cardiovascular Surgery, Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Surgery, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
Learn more about this trial
The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
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