Pilot Study Assessing Oxidative Stress in Children (OxStress)
Recruitment status was Not yet recruiting
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Purpose
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:
- Find out how many sick children have OS in the PICU.
- Find out the normal OS level of healthy children.
- Decide if OS causes adrenal insufficiency.
| Condition | Intervention |
|---|---|
|
Neuroendocrine System |
Drug: Cortrosyn |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Prevalence of Oxidative Stress in Critically Ill Children and Its Relationship to Adrenal Insufficiency; a Pilot Study |
- The primary goal of this pilot study is to establish the OS profile of critically ill children and to correlate it with severity of illness and changes in glucocorticoids receptor structure and function. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Establish the OS profile of healthy children to act as controls and help establish the normal pediatric baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Analysis of clinical data to determine correlation of OS with AI and evaluation of OS as a potential biomarker. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Critically Ill Patients
Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.
|
Drug: Cortrosyn
Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected.
|
|
No Intervention: Healthy Controls
Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
|
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Critically Ill subjects:
- 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".
- Admission to the PICU within the last 24 hours.
- 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:
- Have received steroids within the last 30 days.
- Pre-existing/known neuroendocrine disorder, including but not limited to disorders of the hypothalamus, pituitary, adrenal, pancreas, or thyroid gland.
- Have been treated at anytime with antipsychotic medication.
- Human immunodeficiency virus (HIV) positive.
- Patients who have received etomidate.
- Patients weighing less than or equal to 6 kilograms.
- Developmentally delayed.
- 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.
- 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.
- Parent or legal guardian (or patient when applicable) refuses to sign informed consent.
Healthy control subjects:
- Have received steroids within the last 30 days.
- Have a pre-existing/known neuroendocrine disorder, including but not limited to disorders of the hypothalamus, pituitary, adrenal, pancreas, or thyroid gland.
- Have been treated at anytime with antipsychotic medication.
- Human immunodeficiency virus (HIV) positive.
- Patients who have received etomidate.
- Patients weighing less than or equal to 6 kilograms.
- Developmentally delayed.
- 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.
- 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.
- Parent or legal guardian (or patient when applicable) refuses to sign informed consent.
Contacts and Locations| United States, Georgia | |
| Children's Healthcare of Atlanta at Egleston | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Kiran Hebbar, MBBS 404-785-1600 kiran.hebbar@choa.org | |
| Principal Investigator: Kiran Hebbar, MBBS | |
| Principal Investigator: | Kiran Hebbar, MBBS | Emory University & Children's Healthcare of Atlanta |
More Information
No publications provided
| Responsible Party: | Kiran Hebbar, MBBS, Emory University & Children's Healthcare of Atlanta |
| ClinicalTrials.gov Identifier: | NCT01052207 History of Changes |
| Other Study ID Numbers: | Emory IRB00034236 |
| Study First Received: | January 15, 2010 |
| Last Updated: | January 15, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Emory University:
|
Biological Response Modifiers Endocrinology Hormone Dysfunction Hormones Neuroendocrinology |
Additional relevant MeSH terms:
|
Adrenal Insufficiency Adrenal Gland Diseases Endocrine System Diseases |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013