Optimal Timing for Repair of Right-to-Left Shunt Lesions

NCT ID: NCT00268099

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-11-30

Brief Summary

The primary aim of this study is to determine the optimal timing for repair of right-to-left shunt lesions such as Tetralogy of Fallot defects.

The secondary aim being define the criteria for failing medical therapy.

Detailed Description

In the past, children with right-to-left shunt lesions such as Tetralogy of Fallot defects were palliated with a systemic to pulmonary artery shunt. This prevented cyanosis while the child grew to a size where complete repair could be undertaken. With the improvements in surgical technique and critical care, there is a push to do a primary complete repair for these defects at younger and younger ages. These operations should be delayed as long as possible to allow for growth but not so long that there is unnecessary cyanosis and hypoxemia.

Study Design and Methodology:

Retrospective chart review - approximately 75 patients

Preoperative data:

Diagnosis

Operative data:

Age and weight at surgery Type of surgical procedure Whether pulmonary valve is spared

Postoperative data:

Length of time on ventilator Length of time on inotropes Length of ICU stay Length of hospital stay Complications

Conditions

Congenital Disorders

Study Design

• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Healthcare of Atlanta

OTHER

Sponsor Role: lead

Principal Investigators

Brian E Kogon, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Healthcare of Atlanta

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

05-121

Identifier Type: -

Identifier Source: org_study_id