Congenital Heart Disease
Conditions
Keywords
Biological Response Modifiers, Bypass Surgery, Cardiology, Congenital Heart Disease, Endocrinology, Hormone Dysfunction, Hormones, Neuroendocrinology, Pediatric Surgery
Brief 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 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.
Interventions
OTHERBlood draws
Samples of blood to be drawn before surgery, and nine hours after surgery.
Sponsors
Children's Healthcare of Atlanta
Emory University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NO Outcomes - Study Terminated Without Data. | Study terminated - no data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cardiac Surgery Infants with congenital defects. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | — Participants |
| Age, Categorical >=65 years | — Participants |
| Age, Categorical Between 18 and 65 years | — Participants |
| Region of Enrollment United States | — participants |
| Sex: Female, Male Female | — Participants |
| Sex: Female, Male Male | — Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
NO Outcomes - Study Terminated Without Data.
Time frame: Study terminated - no data.