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

This study has been terminated.
(study not started)
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268099
First received: December 20, 2005
Last updated: March 15, 2012
Last verified: June 2007

December 20, 2005
March 15, 2012
May 2005
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Complete list of historical versions of study NCT00268099 on ClinicalTrials.gov Archive Site
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Optimal Timing for Repair of Right-to-Left Shunt Lesions
Optimal Timing for Repair of Right-to-Left Shunt Lesions

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.

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

Observational
Time Perspective: Retrospective
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Non-Probability Sample

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

Congenital Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
November 2006
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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
Both
up to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00268099
05-121
No
Not Provided
Children's Healthcare of Atlanta
Not Provided
Principal Investigator: Brian E Kogon, MD Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP