Trial Outcomes & Findings for Pilot Study Assessing Oxidative Stress in Children (NCT NCT01052207)
NCT ID: NCT01052207
Last Updated: 2015-06-04
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
102 participants
Primary outcome timeframe
1 years
Results posted on
2015-06-04
Participant Flow
Participant milestones
| Measure |
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.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
42
|
|
Overall Study
COMPLETED
|
60
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study Assessing Oxidative Stress in Children
Baseline characteristics by cohort
| Measure |
Critically Ill Patients
n=60 Participants
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.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected.
|
Healthy Controls
n=42 Participants
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.
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10.9 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
8 years
STANDARD_DEVIATION 4.5 • n=7 Participants
|
9.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
39 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
42 participants
n=7 Participants
|
102 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearsPopulation: PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only.
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.
Outcome measures
| Measure |
Critically Ill Patients
n=60 Participants
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.
Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected.
|
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.
|
|---|---|---|
|
Pediatric Logistic Organ Dysfunction Score in Critically Ill Children
|
15.9 scores on a scale
Standard Deviation 13.7
|
—
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
Outcome data not reported
Adverse Events
Critically Ill Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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.
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
|
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.
|
|---|---|---|
|
Infections and infestations
0
|
—
0/0 • Observational blood draw study. Patient were not subjected to any risks
this study did not place any patients at risk for harm. blood samples were only collected when routine blood (as part of patient care) was being drawn from an established centtral line or arterial line.
|
—
0/0 • Observational blood draw study. Patient were not subjected to any risks
this study did not place any patients at risk for harm. blood samples were only collected when routine blood (as part of patient care) was being drawn from an established centtral line or arterial line.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place