Congenital DisordersNCT00485524
Comparison of NIRS and Serum Lactate to Predict Poor Post-operative Outcomes
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Congenital Disorders
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2002to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass.
Who may be able to join
- 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.
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Congenital Disorders
- Keywords
- Near Infrared Spectroscopy, Serum Lactate Levels, post operative outcomes
- Medical subject headings
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the relationship of serum lactate levels with cardiac diagnosis, operation performed, post-operative course and outcome.
Measured: 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.
Measured: within the first 72hr of intra-operative cardiopulmonary bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2007 (estimated)
- Study startJan 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin O Maher, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00485524
- Sponsor's protocol ID
- 06-177
- Status last verified
- Jul 2008
- First submitted
- 12 Jun 2007
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00485524
- Acronym / sponsor ID
- 06-177
- Conditions
- Congenital Disorders
- Keywords
- Near Infrared Spectroscopy, Serum Lactate Levels, post operative outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin O Maher, MD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Disorders, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.