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Death Following Congenital Heart Surgery

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ClinicalTrials.gov Identifier: NCT00215072
Recruitment Status : Terminated (insufficient number of patient charts to support hypothesis)
First Posted : September 22, 2005
Last Update Posted : March 16, 2012
Sponsor:
Information provided by:
Children's Healthcare of Atlanta

Brief Summary:
The purpose of this study is to elucidate the patterns of death following congenital heart surgery.

Condition or disease
Congenital Heart Surgery Congenital Heart Defects

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.


Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Retrospective
Official Title: Death Following Congenital Heart Surgery
Study Start Date : July 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources





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

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

ClinicalTrials.gov Identifier: NCT00215072     History of Changes
Other Study ID Numbers: 05-090
First Posted: September 22, 2005    Key Record Dates
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