Comparison of NIRS and Serum Lactate to Predict Poor Post-operative Outcomes
| Tracking Information | |||||
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| First Received Date ICMJE | June 12, 2007 | ||||
| Last Updated Date | March 14, 2012 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Evaluate the relationship of serum lactate levels with cardiac diagnosis, operation performed, post-operative course and outcome. [ Time Frame: within the first 72hr of intra-operative cardiopulmonary bypass ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00485524 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. [ Time Frame: within the first 72hr of intra-operative cardiopulmonary bypass ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of NIRS and Serum Lactate to Predict Poor Post-operative Outcomes | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | The retrospective data will be collected on the 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. This information will be reviewed from medical charts between January 1, 2002 and December 31, 2005 at Children's Healthcare of Atlanta, Egleston Hospital. We predict approximately 1000 charts will be reviewed. The investigator wishes to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome; poor outcome defined as initiation of ECMO or death. The investigator then wishes to compare the predictive values of NIRS score and serial serum lactate levels in the above setting to assess their respective efficacies in post-operative cardiac intensive care. The investigator will collect the following information from the medical record: Laboratory: NIRS Indices, serum pH, lactic acid, Co-ox, CBC, Chemistry) Diagnosis Surgical Procedure Incidence of re-operation Length of ICU Stay Length of Hospital Stay Complications Length of Ventilation (how many days on the ventilator) Medications Cross Clamp Time Bypass Time Echocardiogram data Cardiac Catheterization Data Vital Signs Monitored Hemodynamic Measures Final outcome (discharged versus ECMO or death) Demographic data will be summarized for all subjects. For each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range. 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass. |
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| Condition ICMJE | Congenital Disorders | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | July 2008 | ||||
| Primary Completion Date | July 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 1 Month | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00485524 | ||||
| Other Study ID Numbers ICMJE | 06-177 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Children's Healthcare of Atlanta | ||||
| Study Sponsor ICMJE | Children's Healthcare of Atlanta | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Healthcare of Atlanta | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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