A Retrospective Evaluation of the Utility of NIRS Compared With Serum Lactate Levels in Predicting Poor Post-Operative Outcome After Repair of Complex Congenital Heart Disease
Sponsor study identifier
observational
12
1 country
1
Study Start
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Mortality after neonatal cardiac repair remains significant, and neonates who have undergone operative repair of congenital heart disease may experience sudden and unexpected demise. Most of these deaths occur within the first 72 hours and have been attributed to poor systemic cardiac output. The literature currently does not define an early and reliable predictor of poor post-operative outcome in children with congenital heart disease who have recently undergone surgery. The investigator wishes to perform a retrospective chart review to independently define the predictive values of both NIRS score and serial serum lactate levels in the setting of early post-operative morbidity.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
June 12, 2007
Actual (reported)June 13, 2007
Actual (reported)July 2008
Actual (reported)July 2008
Actual (reported)Evaluate the relationship of serum lactate levels with cardiac diagnosis, operation performed, post-operative course and outcome.
within the first 72hr of intra-operative cardiopulmonary bypass
Compare the predictive values of NIRS score and serum lactate levels in the above setting to assess their respective efficacies in post-operative cardiac intensive care.
within the first 72hr of intra-operative cardiopulmonary bypass
pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass.
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Kevin O Maher, MD
Children's Healthcare of Atlanta
12 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2007
First Posted
June 13, 2007
Study Start
January 2002
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2008
Actual (reported)Study Completion
July 2008
Actual (reported)Last Updated
March 16, 2012
Record last verified: 2008-07
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