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| Name | Class |
|---|---|
| Children's Healthcare of Atlanta | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pediatric Logistic Organ Dysfunction Score in Critically Ill Children | 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. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline. | 2 years | |
| Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker. | 2 years |
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Inclusion Criteria:
Critically Ill subjects:
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:
Healthy control subjects:
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Population 1 consists of critically ill patients being care for in quaternary PICU.
Population 2 consists of relatively healthy children undergoing MRI for sedation
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| Name | Affiliation | Role |
|---|---|---|
| Kiran Hebbar, MD, FCCM | Emory University & Children's Healthcare of Atlanta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta at Egleston | Atlanta | Georgia | 30322 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pediatric Logistic Organ Dysfunction Score in Critically Ill Children | 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. | PELOD scores are not calculated for healthy controls. The score was developed to assess critically ill patients only. | Posted | Mean | Standard Deviation | scores on a scale | 1 years |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| 0 | Infections and infestations | Systematic Assessment | 0" Total Number of Participants at Risk This was not an intervention study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kiran Hebbar | CHOA/Emory | 404-785-6135 | khebbar@emory.edu |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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Serum from critically ill patients
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | Establish the OS Profile of Healthy Children to Act as Controls and Help Establish the Normal Pediatric Baseline. | Not Posted | 2 years |
| Secondary | Analysis of Clinical Data to Determine Correlation of OS With AI and Evaluation of OS as a Potential Biomarker. | Not Posted | 2 years |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |