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NCT00215072 Clinical Trial

Death Following Congenital Heart Surgery

Congenital Heart Defects Clinical Trial

Official title:
Death Following Congenital Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00215072
Other study ID # 05-090
Secondary ID
Status Terminated
Phase N/A
First received September 20, 2005
Last updated March 14, 2012
Start date July 2005
Est. completion date February 2007

Study information
Verified date May 2007
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 40
Est. completion date February 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

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

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

Country where clinical trial is conducted

United States, 

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