Pilot Study Assessing Oxidative Stress in Children
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Endocrine |
| Therapuetic Areas: | Endocrinology, Oncology |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 11/23/2013 |
| Start Date: | February 2010 |
| End Date: | December 2011 |
Prevalence of Oxidative Stress in Critically Ill Children and Its Relationship to Adrenal Insufficiency; a Pilot Study
Adrenal insufficiency (AI) is common in critically ill children and adults. AI is a
condition in which the adrenal glands, located above the kidneys, do not make enough
hormones or our body is unable to use the hormones made. A hormone is a chemical that helps
control different kinds of body functions. The hormones being studied can influence blood
pressure and how fast the heart beats. Doctors want to know why children need extra hormones
when they are critically ill. In our pediatric intensive care unit (PICU) we treat AI with a
set of standard orders. By doing this, we have shown that AI is common in many types of
sickness and that blood pressure improves when extra hormones are given. We also found that
people's heart and blood pressure did not always match the level of a certain hormone,
called cortisol, in their blood.
Since cortisol levels alone don't always show AI, and children with normal hormone levels
still benefit from steroids, doctors are looking for a better understanding of AI. Finding
reasons that children develop AI may help doctors find other ways to improve AI.
One promising focus of AI is the role of oxidative stress (OS). OS is a term used to
describe a group of chemical reactions that involve oxygen. Emory's adult intensive care
units have shown a significant increase in OS in critically ill patients. Normally our
body's cortisol acts by binding to glucocorticoid (a class of hormone) receptors (GR) within
cells. Many studies have shown that OS increases steroid resistance by changing the GR
structure and function. Studies involving OS and GR problems have not been done with
children.
We aim to:
1. Find out how many sick children have OS in the PICU.
2. Find out the normal OS level of healthy children.
3. Decide if OS causes adrenal insufficiency.
Inclusion Criteria:
Critically Ill subjects:
1. All patients, birth-18 years, admitted to the pediatric intensive care unit that
require blood to be drawn as part of medical management consistent with "standard of
care".
2. Admission to the PICU within the last 24 hours.
3. Subjects' legal guardian shall possess the ability to understand the purposes and
risks of the study and provide an informed consent signature.
Healthy control subjects:
1. All healthy children, birth-18 years, who are having semi-elective magnetic resonance
imaging (MRI) that require peripheral intravenous (PIV) catheters placed to provide
sedation.
Exclusion Criteria:
Critically Ill subjects:
1. Have received steroids within the last 30 days.
2. Pre-existing/known neuroendocrine disorder, including but not limited to disorders of
the hypothalamus, pituitary, adrenal, pancreas, or thyroid gland.
3. Have been treated at anytime with antipsychotic medication.
4. Human immunodeficiency virus (HIV) positive.
5. Patients who have received etomidate.
6. Patients weighing less than or equal to 6 kilograms.
7. Developmentally delayed.
8. Medical urgency preventing timely administration of the consenting process, or any
condition that, in the opinion of the attending physician, would place the patient at
undue risk by participating.
9. Other technical considerations that would prevent the timely acquisition of
sufficient samples such as (but not limited to) hour of admission or absence of a
study team member.
10. Parent or legal guardian (or patient when applicable) refuses to sign informed
consent.
Healthy control subjects:
1. Have received steroids within the last 30 days.
2. Have a pre-existing/known neuroendocrine disorder, including but not limited to
disorders of the hypothalamus, pituitary, adrenal, pancreas, or thyroid gland.
3. Have been treated at anytime with antipsychotic medication.
4. Human immunodeficiency virus (HIV) positive.
5. Patients who have received etomidate.
6. Patients weighing less than or equal to 6 kilograms.
7. Developmentally delayed.
8. Medical urgency preventing timely administration of the consenting process, or any
condition that, in the opinion of the attending physician, would place the patient at
undue risk by participating.
9. Other technical considerations that would prevent the timely acquisition of
sufficient samples such as (but not limited to) hour of admission or absence of a
study team member.
10. Parent or legal guardian (or patient when applicable) refuses to sign informed
consent.
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