Congenital Heart DiseaseNCT00850720
Study of Possible Brain Hormone Problems After Open Heart Surgery in Infants
An observational study of Congenital Heart Disease, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing… Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Blood draws
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Oct 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 year
- All sexes
- No healthy volunteers
- Child
Study population: Patients at Childrens Healthcare of Atlanta at Egleston
Who may be able to join
- Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.
- Subject must have arterial or central venous lines to be enrolled.
- Subject must have a documented weight of 2.5 Kilograms or greater.
- Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.
Who cannot join
- Medical urgency preventing timely administration of the consenting process.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.
- Have given steroids intravenously (IV) or oral steroids within the last month.
- Have a preexisting neuroendocrine disorder.
- Have been treated with antipsychotic medication.
- Have human immunodeficiency virus (HIV).
- Have received etomidate for intubation.
- Other technical considerations that would prevent acquisition of sufficient samples OR inability / unwillingness of the legal guardian to provide consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
Official title: Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.
- Conditions
- Congenital Heart Disease
- Being tested
- Blood draws
- Keywords
- Biological Response Modifiers, Bypass Surgery, Cardiology, Congenital Heart Disease, Endocrinology, Hormone Dysfunction, Hormones, Neuroendocrinology, Pediatric Surgery
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood drawsOther
Also called Tests being analyzed:, • Cortisol, • Vasopressin (ADH), • Cortisol Free
Samples of blood to be drawn before surgery, and nine hours after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Surgery | Infants with congenital defects. Receives: Other: Blood draws |
What is being measured
The primary outcome is the main question the study is designed to answer.
NO Outcomes - Study Terminated Without Data.
Measured: Study terminated - no data.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2009
- Study completionOct 2009
Why it stopped: Inability to recruit / logistic problems.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Responsible party
- Principal investigator, Kiran Hebbar, Emory University
- Investigators
- Kiran Hebbar, MBBS, Principal investigator, Emory University & Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850720
- Sponsor's protocol ID
- IRB00007443
- Status last verified
- Nov 2013
- First submitted
- 24 Feb 2009
- Last updated
- 7 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Neuroendocrine Dysfunction in the Pediatric Cardiopulmonary Bypass Patient
- ClinicalTrials.gov ID
- NCT00850720
- Acronym / sponsor ID
- IRB00007443
- Conditions
- Congenital Heart Disease
- Keywords
- Biological Response Modifiers, Bypass Surgery, Cardiology, Congenital Heart Disease, Endocrinology, Hormone Dysfunction, Hormones, Neuroendocrinology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inability to recruit / logistic problems.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Children's Healthcare of Atlanta
- Study start
- Mar 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 7 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate specific hormone levels in children undergoing heart surgery in order to identify patterns associated with any unstable vital signs. The data collected will provide preliminary answers to the question "Are hormone values a determining factor for drug administration and dosing levels?" and help establish the benefits of routine steroid and hormone administration. Sixty subjects will be enrolled. Blood samples will be drawn before the surgery,and again nine hours after surgery for analysis. Other patient data such as medications, vital signs, routine lab values and treatments will also be analyzed. As our current standard of care includes routine doses of steroids, we believe this study will increase our general knowledge and improve the care of these critically ill children. The study will also provide the foundation needed for grant support from the American Heart Association, allowing for future larger scale studies.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Surgery | – | Other: Blood drawsInfants with congenital defects. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients at Childrens Healthcare of Atlanta at Egleston
Key inclusion criteria (4 listed)
- Children with congenital heart disease requiring cardiopulmonary bypass(CPB) surgery less than 1 year of age admitted to the cardiac intensive care unit (CICU) preoperatively, who required blood sampling as part of their care.
- Subject must have arterial or central venous lines to be enrolled.
- Subject must have a documented weight of 2.5 Kilograms or greater.
- Subjects' legal guardian shall possess the ability to understand the purposes and risks of the study and provide an informed consent signature.
Key exclusion criteria (8 listed)
- Medical urgency preventing timely administration of the consenting process.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions might include, but are not limited to, anemia or coagulopathy.
- Have given steroids intravenously (IV) or oral steroids within the last month.
- Have a preexisting neuroendocrine disorder.
- Have been treated with antipsychotic medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood drawsAlso: Tests being analyzed:, • Cortisol, • Vasopressin (ADH), • Cortisol FreeSamples of blood to be drawn before surgery, and nine hours after surgery. | Other | Cardiac Surgery |
Primary outcome
NO Outcomes - Study Terminated Without Data.
Time frame: Study terminated - no data.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kiran Hebbar, MBBS principal investigator
Emory University & 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 Heart Disease, run by Emory University 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 4 inclusion and 8 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: stopped early, as of the sponsor's last update on 7 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 7 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
NO Outcomes - Study Terminated Without Data. (time frame: Study terminated - no data.). 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 7 Jan 2014.