Congenital Heart Diseases
Conditions
Keywords
congenital heart diseases, cardiopulmonary bypass, Pediatric, sevoflurane
Brief summary
During repair of a congenital heart defect the child is exposed to myocardial hypoxia. Recent studies have suggested that the paediatric myocardium is more sensitive to hypoxia and cardioplegic arrest than the adult. The protective effect of halogenated agents on ischaemia and reperfusion injury has been investigated widely in adults. The investigators hypothesis that sevoflurane applied during cardiopulmonary bypass might afford better myocardial protection during paediatric cardiac surgery.
Interventions
DRUGSevoflurane
Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
OTHERControl
Patients will receive only oxygen and air through oxygenator
Sponsors
Xijing Hospital
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
No
Inclusion criteria
* pediatric patients (body weight \< 10 kg) * diagnosed with congenital heart diseases * scheduled for repair operation with CPB * in the Department of Cardiovascular Surgery, Xijing Hospital
Exclusion criteria
* systemic infections * other systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all cause mortality | within the first 30 days (plus or minus 3 days) after surgery | All cause mortality after the cardaic surgery, patients will be followed up for 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| serum cTnI concentrations | 48 h after the surgery | serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation. |
Countries
China
Contacts
Primary ContactZhenxiao Jin, Ph.D
Outcome results
None listed