N/A
Completed N=102
Pilot Study Assessing Oxidative Stress in Children
Source: ClinicalTrials.gov NCT01052207 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
Sep 2014
Primary outcomePrimary: Pediatric Logistic Organ Dysfunction Score in Critically Ill Children — 15.9 scores on a scale
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pediatric Logistic Organ Dysfunction Score in Critically Ill Children |
15.9 | — |
| SECONDARY Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline. |
— | — |
| SECONDARY Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker. |
— | — |
Eligibility Criteria
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:
- 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.
Data sourced from ClinicalTrials.gov (NCT01052207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.