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

Not Applicable

Completed

• Conditions: Congenital Heart Disease
• Interventions: Drug: MP (moderate potassium) group; Drug: HP (High potassium) group

• Registration Number: NCT01479049
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-03
• Study Completion: 2010-10
• Study First Submitted: 2011-10-07
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-23
• Last Update Submitted: 2011-11-23
• Study First Posted: 2011-11-24
• Last Update Posted: 2011-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MP group	MP (moderate potassium) group	Hearts are arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L) during cardiac surgery.
HP group	HP (High potassium) group	Hearts were arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L) during cardiac operation

Primary Outcome Measures

Name	Time	Method
post-operative Serum cTnI concentration decreased significantly in 24hours	24h after myocardial reperfusion	myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.

Trial Locations

Locations (1)

Department of Cardiovascular Surgery, Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China