The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 7, 2011
CompletedFirst Posted
Study publicly available on registry
October 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedNovember 28, 2011
November 1, 2011
4 months
October 7, 2011
November 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
serum cTnI concentrations
48 h after the surgery
Study Arms (2)
Sevoflurane
EXPERIMENTALPatients will receive 2% sevoflurane via oxygenator during CPB
Control
NO INTERVENTIONPatients will receive only oxygen and air through oxygenator
Interventions
Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- systemic infections
- other systemic diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
Study Sites (1)
Department of Cardiovascular Surgery, Xijing Hospital
Xi'an, Shaanxi, 710032, China
Related Publications (1)
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.
PMID: 26418205DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhenxiao Jin, PhD
Department of Cardiovascular Surgery, Xijing Hospital
Central Study Contacts
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
October 13, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
November 28, 2011
Record last verified: 2011-11