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

This study has been completed.
Sponsor:
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
  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
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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 August 28, 2014