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NCT00268099 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00268099
Other study ID # 05-121
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated March 15, 2012
Start date May 2005
Est. completion date November 2006

Study information
Verified date June 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

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.

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 information / eligibility
Status Terminated
Enrollment 75
Est. completion date November 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- those who do not meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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