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Death Following Congenital Heart Surgery

This study has been terminated.
(insufficient number of patient charts to support hypothesis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00215072
First Posted: September 22, 2005
Last Update Posted: March 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Healthcare of Atlanta
  Purpose
The purpose of this study is to elucidate the patterns of death following congenital heart surgery.

Condition
Congenital Heart Surgery Congenital Heart Defects

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Death Following Congenital Heart Surgery

Resource links provided by NLM:


Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 40
Study Start Date: July 2005
Study Completion Date: February 2007
Detailed Description:

With the improvements in instrumentation, surgical technique, and critical care, the overall mortality following congenital heart surgery has become extremely low. Also, with the introduction of extracorporeal support (ECMO), especially in the emergency setting, acute deaths are extremely rare. The majority of post-operative deaths seem to be the result of a prolonged hospitalization with a progressive decline to multi-system organ failure.

The primary aim of the study is to elucidate the patterns of death following congenital heart surgery. The secondary aims of the study are to discover patterns and consistencies among the deaths and to discover points of potential intervention to reduce surgical mortality. The study will be conducted through a retrospective chart review of approximately 40 patients.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the congenital surgery database
Criteria

Inclusion Criteria:

  • Patients in the congenital surgery database
  • Post-operative surgical mortality
  • Deaths within 30 days of surgery
  • Deaths prior to ever leaving the hospital
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00215072


Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Brian Kogon, MD Emory University
  More Information

ClinicalTrials.gov Identifier: NCT00215072     History of Changes
Other Study ID Numbers: 05-090
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: March 16, 2012
Last Verified: May 2007

Keywords provided by Children's Healthcare of Atlanta:
Death after heart surgery
surgical mortality
post-operative mortality
pediatric health
cardiac

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities