The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01450956
First received: October 7, 2011
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

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 Intervention
Congenital Heart Diseases
Drug: Sevoflurane
Other: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: Yes ]
    All cause mortality after the cardaic surgery, patients will be followed up for 30 days


Secondary Outcome Measures:
  • serum cTnI concentrations [ Time Frame: 48 h after the surgery ] [ Designated as safety issue: No ]
    serial serum cTnI concentrations will be determined to whether sevoflurane application during CPB will decrease the cTnI release after operation.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01450956     History of Changes
Other Study ID Numbers: XJXZ2011-010
Study First Received: October 7, 2011
Last Updated: November 24, 2011
Health Authority: China: Ministry of Health

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014