Viewing Study NCT00215072



Ignite Creation Date: 2024-05-05 @ 12:02 PM
Last Modification Date: 2024-10-26 @ 9:18 AM
Study NCT ID: NCT00215072
Status: TERMINATED
Last Update Posted: 2012-03-16
First Post: 2005-09-20

Brief Title: Death Following Congenital Heart Surgery
Sponsor: Childrens Healthcare of Atlanta
Organization: Childrens Healthcare of Atlanta

Study Overview

Official Title: Death Following Congenital Heart Surgery
Status: TERMINATED
Status Verified Date: 2007-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: insufficient number of patient charts to support hypothesis
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to elucidate the patterns of death following congenital heart surgery
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None