Pilot Study Assessing Oxidative Stress in Children (OxStress)
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.
|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 ]
|Study Start Date:||February 2010|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052207
|United States, Georgia|
|Children's Healthcare of Atlanta at Egleston|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Kiran Hebbar, MBBS||Emory University & Children's Healthcare of Atlanta|