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

NCT01479049 | Completed DMC

• 1 other identifier: XJXZ2009-1010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

congenital heart disease; cardiac surgery; cardiopulmonary bypass; cardioplegia

Outcome Measures

Primary Outcomes (1)

• post-operative Serum cTnI concentration decreased significantly in 24hours

  myocardial injury could be sensitively reflected by post operative Serum cTnI concentration.

  24h after myocardial reperfusion

Study Arms (2)

MP group

EXPERIMENTAL

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

Drug: MP (moderate potassium) group

HP group

ACTIVE COMPARATOR

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

Drug: HP (High potassium) group

Interventions

MP (moderate potassium) group DRUG

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

Also known as: moderate potassium cardioplegia

MP group

HP (High potassium) group DRUG

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

Also known as: High potassium cardioplegia

HP group

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• other systemic diseases

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Department of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Zhenxiao Jin, PhD

  Department of Cardiovascular Surgery, Xijing Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: November 24, 2011
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 24, 2011

Record last verified: 2011-11

Locations

CN (1)