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Managing Cyanosis Following Bidirectional Glenn Operation

NCT ID: NCT00327886

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-02-28

Brief Summary

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The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.

Detailed Description

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Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic.

Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005.

We will assign each chart a unique study number and collect data of:

date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications

Conditions

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Congenital Disorders

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Infants
* Bidirectional Glenn operation between 1/1/03-12/31/05
* Significant Cyanosis
Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Healthcare of Atlanta

OTHER

Sponsor Role lead

Principal Investigators

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Janet M Simsic, MD

Role: PRINCIPAL_INVESTIGATOR

Sibley Heart Center Cardiology, Children's Healthcare of Atlanta

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

Countries

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United States

Other Identifiers

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06-029

Identifier Type: -

Identifier Source: org_study_id