Optimal Timing for Repair of Right-to-Left Shunt Lesions
- Conditions
- Congenital Disorders
- Registration Number
- NCT00268099
- Lead Sponsor
- Children's Healthcare of Atlanta
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 75
- patients in the congenital surgery database who have undergone repair of a Tetralogy of Fallot defect
- those who do not meet inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States