Back to resultsThe Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
Primary Purpose
Congenital Heart Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Control
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Diseases focused on measuring congenital heart diseases, cardiopulmonary bypass, Pediatric, sevoflurane
Eligibility Criteria
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
Sites / Locations
- Department of Cardiovascular Surgery, Xijing HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sevoflurane
Control
Arm Description
Patients will receive 2% sevoflurane via oxygenator during CPB
Patients will receive only oxygen and air through oxygenator
Outcomes
Primary Outcome Measures
all cause mortality
All cause mortality after the cardaic surgery, patients will be followed up for 30 days
Secondary Outcome Measures
serum cTnI concentrations
serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01450956
Brief Title
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
Official Title
The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Diseases
Keywords
congenital heart diseases, cardiopulmonary bypass, Pediatric, sevoflurane
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
Patients will receive 2% sevoflurane via oxygenator during CPB
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive only oxygen and air through oxygenator
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Patients will receive only oxygen and air through oxygenator
Primary Outcome Measure Information:
Title
all cause mortality
Description
All cause mortality after the cardaic surgery, patients will be followed up for 30 days
Time Frame
within the first 30 days (plus or minus 3 days) after surgery
Secondary Outcome Measure Information:
Title
serum cTnI concentrations
Description
serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.
Time Frame
48 h after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhenxiao Jin, Ph.D
Phone
86-29-84771022
Email
jinzx10262@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, PhD
Organizational Affiliation
Department of Cardiovascular Surgery, Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Surgery, Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenxiao Jin, PhD
Phone
86-29-84771022
Email
jinzx10262@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Hongyan Xiong, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
26418205
Citation
Xiong HY, Liu Y, Shu DC, Zhang SL, Qian X, Duan WX, Cheng L, Yu SQ, Jin ZX. Effects of Sevoflurane Inhalation During Cardiopulmonary Bypass on Pediatric Patients: A Randomized Controlled Clinical Trial. ASAIO J. 2016 Jan-Feb;62(1):63-8. doi: 10.1097/MAT.0000000000000285.
Results Reference
derived
Learn more about this trial
The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
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