The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

Congenital Heart Diseases Clinical Trial

Official title:

The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01450956
• Other study ID #: XJXZ2011-010
• Status: Unknown status
• Phase: N/A
• First received: October 7, 2011
• Last updated: November 24, 2011
• Start date: September 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2011
• Source: Xijing Hospital
• Contact: Zhenxiao Jin, Ph.D
• Phone: 86-29-84771022
• Email: jinzx10262[@]yahoo.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 100
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Diseases
• Heart Defects, Congenital
• Heart Diseases

Intervention

Drug:
• Sevoflurane
Sevoflurane will be given at a concentration of 2% through oxygenator during CPB

Other:
• Control
Patients will receive only oxygen and air through oxygenator

Locations

Country	Name	City	State
China	Department of Cardiovascular Surgery, Xijing Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality	All cause mortality after the cardaic surgery, patients will be followed up for 30 days	within the first 30 days (plus or minus 3 days) after surgery
Secondary	serum cTnI concentrations	serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.	48 h after the surgery