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

Congenital Disorders Clinical Trial

Official title: Optimal Timing for Repair of Right-to-Left Shunt Lesions

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Congenital Disorders

• NCT number: NCT00268099
• Study type: Observational
• Source: Children's Healthcare of Atlanta
• Status: Terminated
• Phase: N/A
• Start date: May 2005
• Completion date: November 2006