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The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01450956
Recruitment Status : Unknown
Verified November 2011 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : October 13, 2011
Last Update Posted : November 28, 2011
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
Drug Information available for: Sevoflurane

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




Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01450956


Contacts
Contact: Zhenxiao Jin, Ph.D 86-29-84771022 jinzx10262@yahoo.com.cn

Locations
China, Shaanxi
Department of Cardiovascular Surgery, Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Zhenxiao Jin, PhD    86-29-84771022    jinzx10262@yahoo.com.cn   
Sub-Investigator: Hongyan Xiong, MD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Zhenxiao Jin, PhD Department of Cardiovascular Surgery, Xijing Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01450956     History of Changes
Other Study ID Numbers: XJXZ2011-010
First Posted: October 13, 2011    Key Record Dates
Last Update Posted: November 28, 2011
Last Verified: November 2011

Keywords provided by Xijing Hospital:
congenital heart diseases
cardiopulmonary bypass
Pediatric
sevoflurane

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities
Sevoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs