Pilot Study Assessing Oxidative Stress in Children (OxStress)

This study has been completed.
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Kiran Hebbar, Emory University
ClinicalTrials.gov Identifier:
NCT01052207
First received: January 15, 2010
Last updated: September 19, 2014
Last verified: September 2014
  Purpose

Role fo oxidative stress in adrenal insufficiency has not been studied. The degree of oxidative stress and it's role in pediatric critical illness is unknown. Potential for significant alterations to many of thew body's regulatory pathways may result from severe oxidative stress. Further is needed to delineate what if any role oxidative stress may play


Condition
Adrenal Insufficiency
Critical Illness

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Oxidative Stress in Critically Ill Children and Its Relationship to Adrenal Insufficiency; a Pilot Study

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pediatric Logistic Organ Dysfunction Score in Critically Ill Children [ Time Frame: 1 years ] [ Designated as safety issue: No ]

    Pediatric Logistic Organ Dysfunction also known as the PELOD Score is a marker of severity of illness for Critically ill children. The PELOD includes six organ dysfunctions and 12 variables.

    To calculate the PELOD score, each organ dysfunction received points for the single variable associated with the most points. The minimum number that can be assigned to an organ is 0 and the maximum number of points for an organ is 20, and the maximum possible PELOD score is 71. Organ dysfunction is identified if the score for any organ system was more than 0.



Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

Serum from critically ill patients


Enrollment: 102
Study Start Date: February 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Population 1 consists of critically ill patients being care for in quaternary PICU.

Population 2 consists of relatively healthy children undergoing MRI for sedation

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052207

Locations
United States, Georgia
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Kiran Hebbar, MD, FCCM Emory University & Children's Healthcare of Atlanta
  More Information

No publications provided

Responsible Party: Kiran Hebbar, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT01052207     History of Changes
Other Study ID Numbers: IRB00034236
Study First Received: January 15, 2010
Results First Received: December 9, 2013
Last Updated: September 19, 2014
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
Critical Illness
Adrenal Gland Diseases
Disease Attributes
Endocrine System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 20, 2014