Comparison of NIRS and Serum Lactate to Predict Poor Post-operative Outcomes

NCT00485524 | Completed

• 1 other identifier: 06-177
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Disorders

Keywords

Near Infrared Spectroscopy; Serum Lactate Levels; post operative outcomes

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass.

You may qualify if:

• Egleston Hospital, Children's Healthcare of Atlanta patients' charts
• Jan. 1, 2002 through Dec. 31,2005
• data collected on NIRS score and serum levels within the first 72 hours, in the pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass.

Sponsors & Collaborators

• Children's Healthcare of Atlanta: lead

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kevin O Maher, MD

  Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2007
• First Posted: June 13, 2007
• Study Start: January 1, 2002
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: March 16, 2012

Record last verified: 2008-07

Locations

US (1)