Primary outcomeMean· 1 years
Pediatric Logistic Organ Dysfunction Score in Critically Ill Children
| Group | Value (scores on a scale) | Spread |
|---|---|---|
| Critically Ill Patients | 15.9 | 13.7 |
| Healthy Controls | not posted | – |
Trial · Observational
CompletedPhase not statedResults postedRegistry dataPilot Study Assessing Oxidative Stress in Children
Short name OxStress
NCTNCT01052207 (opens ClinicalTrials.gov in a new tab)Other idIRB00034236
This trial does not test a peptide that PepBank tracks.
- Names ACTH (corticotropin), does not test it. It appears in the description.
Overview
- Status
- Completed
- Phase
- Phase not stated
- Enrollment
- 102 participants (actual)
- Sponsor
- Emory University · Other
- Design
- Not stated
- Countries
1 country
United States
- Start
- Feb 2010
- Primary completion
- Jun 2011
- Completion
- Jun 2011
- First posted
- 20 Jan 2010 (estimated)
- Last update posted
- 4 Jun 2015 (estimated)
- Conditions
- Adrenal Insufficiency · Critical Illness
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020112012
- Ph –
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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
Arms2
Other
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.
Other
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Pediatric Logistic Organ Dysfunction Score in Critically Ill Children
Time frame · 1 years
Registry description
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 outcomes(2)
Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.
Time frame · 2 years
Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.
Time frame · 2 years
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcome· 2 years
Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline.
| Group | Value |
|---|
Secondary outcome· 2 years
Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker.
| Group | Value |
|---|
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Critically Ill PatientsEvaluation 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. Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care | – | 0 / 0 | 0 / 0 |
| Healthy ControlsHealthy 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. | – | 0 / 0 | 0 / 0 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 1 Day up to 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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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