Critical IllnessNCT00207896
Neuroendocrine Dysfunction in Critically Ill Pediatric Patients
An observational study of Critical Illness, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Research studies in adults have shown that certain hormones may be decreased or may not work normally which contributes to how sick a person becomes. The purpose of this project is to study hormones in children. Read more about this study
- Who is it for?
- Ages 5 months and older
- Conditions the study is for
- Critical Illness
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Aug 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted to PICU
Who may be able to join
- All patients, birth - 18 years of age
- Admitted to the pediatric intensive care unit requiring blood to be drawn as part of medical management consistent with "standard of care".
Who cannot join
- Elective post-operative surgical patients.
- Pre-existing/known neuroendocrine disorder including, but not limited to, disorders of the hypothalamus, pituitary, adrenal, or thyroid gland.
- Patients being treated with or having a recent history of taking anti-psychotic medications (e.g. ingestion).
- Patients whose laboratory specimens have already been drawn prior to admission (emergency room or another facility) and who do not require further blood draws for medical management within a 12 hour window.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
About this study
Official title: Defining the Prevalence of Acute Neuroendocrine Dysfunction and Correlating the Dysfunction With Outcomes in Critically Ill Pediatric Patients: A Pilot Study
Research studies in adults have shown that certain hormones may be decreased or may not work normally which contributes to how sick a person becomes. The purpose of this project is to study hormones in children. The investigators will look to see if a decrease of certain hormone levels affects how sick a child may become. This study is intended to develop a connection between hormone levels and severity of illness. It is hoped that the information gathered will help develop further studies that may more clearly explain the role of hormones in critically ill children and possibly the introduction of hormone replacement in critical illness.
Read the detailed description
Neuroendocrine dysfunction is an abnormality in the production or release of certain hormones. Studies completed in adult patients have shown abnormal hormone levels in critical illness can contribute to how long patients stay in the intensive care unit, how severe their illness is and whether or not they survive. In children hormones are produced differently and have different functions. Depending on the particular illness in question hormonal dysfunction may have grave clinical consequences.
Thus far, there have been few studies that have examined neuroendocrine dysfunction in children. The aim of our study is to identify the common hormone responses in children, and to identify any connection between hormone levels and outcomes (likelihood of child staying in the intensive care unit for multiple days, etc.).
To explore these aims we will draw blood from all critically ill patients admitted to the pediatric intensive care unit (PICU) and check various hormone levels. Only those patients who require blood samples as part of their admission will have blood tests for certain hormone levels. No change will be made from established standard of care for a patient's particular critical illness.
The study is designed to examine hormone responses to critical illness and identify a connection between hormone levels and severity of illness. Based on these lab values we intend to lay a foundation for further studies that may more clearly explain the role of hormones in critically ill children, and possibly the introduction of hormone replacement in critical illness.
- Conditions
- Critical Illness
- Keywords
- Pediatric Intensive Care, Neuroendocrine Dysfunction
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the prevalence of neuroendocrine dysfunction in critically ill pediatric patients.
Conclued that neuroendocrine deficiency is present in critically ill pediatric patients. Prevalence is not greater in septic patients. Seventy-three children were enrolled over 13-month period. Larger scale studies are necessary to determine if presence of NEAD, or specific combinations of axis deficiency, is important in predicting outcomes or benefit of early hormonal replacement therapies in critically ill children.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James D Fortenberry, MD, Principal investigator, Children's Healthcare of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207896
- Sponsor's protocol ID
- 04-068
- Status last verified
- Nov 2014
- First submitted
- 13 Sep 2005
- Last updated
- 2 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining the Prevalence of Acute Neuroendocrine Dysfunction and Correlating the Dysfunction With Outcomes in Critically Ill Pediatric Patients: A Pilot Study
- ClinicalTrials.gov ID
- NCT00207896
- Acronym / sponsor ID
- 04-068
- Conditions
- Critical Illness
- Keywords
- Pediatric Intensive Care, Neuroendocrine Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research studies in adults have shown that certain hormones may be decreased or may not work normally which contributes to how sick a person becomes. The purpose of this project is to study hormones in children. The investigators will look to see if a decrease of certain hormone levels affects how sick a child may become. This study is intended to develop a connection between hormone levels and severity of illness. It is hoped that the information gathered will help develop further studies that may more clearly explain the role of hormones in critically ill children and possibly the introduction of hormone replacement in critical illness.
Detailed description
Neuroendocrine dysfunction is an abnormality in the production or release of certain hormones. Studies completed in adult patients have shown abnormal hormone levels in critical illness can contribute to how long patients stay in the intensive care unit, how severe their illness is and whether or not they survive. In children hormones are produced differently and have different functions. Depending on the particular illness in question hormonal dysfunction may have grave clinical consequences.
Thus far, there have been few studies that have examined neuroendocrine dysfunction in children. The aim of our study is to identify the common hormone responses in children, and to identify any connection between hormone levels and outcomes (likelihood of child staying in the intensive care unit for multiple days, etc.).
To explore these aims we will draw blood from all critically ill patients admitted to the pediatric intensive care unit (PICU) and check various hormone levels. Only those patients who require blood samples as part of their admission will have blood tests for certain hormone levels. No change will be made from established standard of care for a patient's particular critical illness.
The study is designed to examine hormone responses to critical illness and identify a connection between hormone levels and severity of illness. Based on these lab values we intend to lay a foundation for further studies that may more clearly explain the role of hormones in critically ill children, and possibly the introduction of hormone replacement in critical illness.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted to PICU
Key inclusion criteria (2 listed)
- All patients, birth - 18 years of age
- Admitted to the pediatric intensive care unit requiring blood to be drawn as part of medical management consistent with "standard of care".
Key exclusion criteria (4 listed)
- Elective post-operative surgical patients.
- Pre-existing/known neuroendocrine disorder including, but not limited to, disorders of the hypothalamus, pituitary, adrenal, or thyroid gland.
- Patients being treated with or having a recent history of taking anti-psychotic medications (e.g. ingestion).
- Patients whose laboratory specimens have already been drawn prior to admission (emergency room or another facility) and who do not require further blood draws for medical management within a 12 hour window.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the prevalence of neuroendocrine dysfunction in critically ill pediatric patients.
Time frame: 13 months
Conclued that neuroendocrine deficiency is present in critically ill pediatric patients. Prevalence is not greater in septic patients. Seventy-three children were enrolled over 13-month period. Larger scale studies are necessary to determine if presence of NEAD, or specific combinations of axis deficiency, is important in predicting outcomes or benefit of early hormonal replacement therapies in critically ill children.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James D Fortenberry, MD principal investigator
Children's Healthcare of Atlanta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the prevalence of neuroendocrine dysfunction in critically ill pediatric patients. (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.