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

The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01479049

Enrollment

100

Registered

2011-11-24

Start date

2009-10-31

Completion date

2010-10-31

Last updated

2011-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

congenital heart disease, cardiac surgery, cardiopulmonary bypass, cardioplegia

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.

Interventions

DRUGMP (moderate potassium) group

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

DRUGHP (High potassium) group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Months to 24 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026