The Protective Effects of Sevoflurane in Pediatric Cardiac Surgery

November 24, 2011 updated by: Xijing Hospital

The Protective Effects of Sevoflurane Application During CPB on Pediatric Patients Underwent Cardiac Surgery: a Randomized, Controlled, Blinded Clinical Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Cardiovascular Surgery, Xijing Hospital
        • Contact:
        • Sub-Investigator:
          • Hongyan Xiong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 30 days (plus or minus 3 days) after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
48 h after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Zhenxiao Jin, PhD, Department of Cardiovascular Surgery, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2012

Study Registration Dates

First Submitted

October 7, 2011

First Submitted That Met QC Criteria

October 12, 2011

First Posted (Estimate)

October 13, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2011

Last Update Submitted That Met QC Criteria

November 24, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJXZ2011-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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