The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

• Sponsor: Xijing Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01450956
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 4
• Patients Per Site Per Month: 24.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Diseases	Drug: Sevoflurane; Other: Control	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
• Study Start Date: Sep 1, 2011
• Anticipated Primary Completion Date: Jan 1, 2012
• Anticipated Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sevoflurane Patients will receive 2% sevoflurane via oxygenator during CPB	Drug: Sevoflurane; Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
No Intervention: Control Patients will receive only oxygen and air through oxygenator	Other: Control; Patients will receive only oxygen and air through oxygenator

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 24 Months
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Cardiovascular Surgery, Xijing Hospital	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Principal Investigator: Zhenxiao Jin, PhD, Department of Cardiovascular Surgery, Xijing Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT01450956
• Other Study ID Numbers: XJXZ2011-010
• First Posted: Oct 13, 2011
• Last Update Posted: Nov 28, 2011
• Last Verified: Nov 1, 2011

• Keywords provided by Xijing Hospital: congenital heart diseases; cardiopulmonary bypass; Pediatric; sevoflurane
• Additional relevant MeSH terms: Heart Diseases; Heart Defects, Congenital; Sevoflurane

Study Results

No Results Posted as of Nov 28, 2011