The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

NCT ID: NCT01450956

Last Updated: 2011-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Diseases

Keywords

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congenital heart diseases cardiopulmonary bypass Pediatric sevoflurane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sevoflurane

Patients will receive 2% sevoflurane via oxygenator during CPB

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

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

Control

Patients will receive only oxygen and air through oxygenator

Group Type NO_INTERVENTION

Control

Intervention Type OTHER

Patients will receive only oxygen and air through oxygenator

Interventions

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Sevoflurane

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

Intervention Type DRUG

Control

Patients will receive only oxygen and air through oxygenator

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhenxiao Jin, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Surgery, Xijing Hospital

Locations

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Department of Cardiovascular Surgery, Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenxiao Jin, Ph.D

Role: CONTACT

Phone: 86-29-84771022

Email: [email protected]

Facility Contacts

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Zhenxiao Jin, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26418205 (View on PubMed)

Other Identifiers

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XJXZ2011-010

Identifier Type: -

Identifier Source: org_study_id