The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
This study has been completed.
Sponsor:
Xijing Hospital
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01479049
First received: October 7, 2011
Last updated: November 23, 2011
Last verified: November 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congenital Heart Disease |
Drug: MP (moderate potassium) group Drug: HP (High potassium) group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Xijing Hospital:
Primary Outcome Measures:
- post-operative Serum cTnI concentration decreased significantly in 24hours [ Time Frame: 24h after myocardial reperfusion ] [ Designated as safety issue: No ]myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.
| Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: MP group
Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.
|
Drug: MP (moderate potassium) group
Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation
Other Name: moderate potassium cardioplegia
|
|
Active Comparator: HP group
Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation
|
Drug: HP (High potassium) group
Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.
Other Name: High potassium cardioplegia
|
Eligibility| Ages Eligible for Study: | 1 Month to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479049
Locations
| China, Shaanxi | |
| Department of Cardiovascular Surgery, Xijing Hospital | |
| Xi'an, Shaanxi, China, 710032 | |
Sponsors and Collaborators
Xijing Hospital
Investigators
| Principal Investigator: | Zhenxiao Jin, PhD | Department of Cardiovascular Surgery, Xijing Hospital |
More Information
No publications provided
| Responsible Party: | Xijing Hospital |
| ClinicalTrials.gov Identifier: | NCT01479049 History of Changes |
| Other Study ID Numbers: | XJXZ2009-1010 |
| Study First Received: | October 7, 2011 |
| Last Updated: | November 23, 2011 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Xijing Hospital:
|
congenital heart disease cardiac surgery cardiopulmonary bypass cardioplegia |
Additional relevant MeSH terms:
|
Heart Diseases Heart Defects, Congenital Cardiovascular Diseases Cardiovascular Abnormalities Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 22, 2013