Adrenal InsufficiencyNCT01265966
Cortisol Response to Moderate and Deep Sedation in Children
An observational study of Adrenal Insufficiency, run by Tripler Army Medical Center at 1 site in United States.
Trial summary
Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jul 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Male and female military health care beneficiaries ages 3 months to 18 years of age presenting to the Tripler Army Medical Center pediatric sedation uni twho do not have any diagnosis consistent with or concerning for adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
Who may be able to join
- Child presenting for routine sedation to the TAMC Pediatric Sedation Center.
- Age 3 months to 18 years of age.
- If female age 12 or greater OR menstruating, must not be pregnant.
Who cannot join
- Must not have the diagnosis of adrenal insufficiency or any concerns for possible adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
- Current treatment with oral steroids or has been on oral steroids in the last 3 months.
- The use of regular inhaled corticosteroids for asthma controller treatment or intranasal steroids for allergic rhinitis is specifically NOT an exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of the Normal Cortisol Response to Moderate and Deep Sedation in Adrenally Sufficient Children
Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. Animal data shows significant alterations in steroid intermediates under anesthesia regardless of the procedure performed. Prior studies in children show general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the effects of moderate and deep sedation on cortisol levels during different types of procedures are unknown. General medical practice varies considerably among providers; some provide stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive and invasive procedures for patients with known adrenal insufficiency, but the doses given vary considerably. Others provide stress dosing only for the most invasive procedures in this population of patients. Currently there is no published normative data on changes in cortisol levels under moderate and deep sedation in adrenally sufficient children, so the normal response we are trying to mimic is unknown.
We propose to measure salivary cortisol levels prospectively in adrenally sufficient children undergoing moderate and deep sedation to determine the normal cortisol response to the stress of sedation for both invasive and non-invasive procedures.
Read more
Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI, echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy) to determine what the normal cortisol response is to the stress of sedation during these procedures using various anesthetic agents.
The primary outcome variable will be to determine peak salivary cortisol measurements during non-invasive and invasive procedures under different levels of sedation using various anesthetic agents, and correlate these with known norms in children to determine if the patient's hypothalamic-pituitary-adrenal axis is under stress.
- Conditions
- Adrenal Insufficiency
- Keywords
- Moderate Sedation, Sedation, Deep
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate Sedation | Children undergoing moderate sedation for procedures. | |
| Deep Sedation | Children undergoing deep sedation for procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Peak Salivary Cortisol Level
Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.
Measured: Baseline, then every 30 minutes, and at end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tripler Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jordan Pinsker, Tripler Army Medical Center
- Investigators
- Angela Hsu, MD, Principal investigator, Tripler Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265966
- Sponsor's protocol ID
- TAMC 32H10
- Status last verified
- Mar 2013
- First submitted
- 22 Dec 2010
- Last updated
- 11 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hsu AA, von Elten K, Chan D, Flynn T, Walker K, Barnhill J, Naun C, Pedersen AM, Ponaman M, Fredericks GJ, Crudo DF, Pinsker JE. Characterization of the cortisol stress response to sedation and anesthesia in children. J Clin Endocrinol Metab. 2012 Oct;97(10):E1830-5. doi: 10.1210/jc.2012-1499. Epub 2012 Aug 1.
PubMed 22855336
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Normal Cortisol Response to Moderate and Deep Sedation in Adrenally Sufficient Children
- ClinicalTrials.gov ID
- NCT01265966
- Acronym / sponsor ID
- TAMC 32H10
- Conditions
- Adrenal Insufficiency
- Keywords
- Moderate Sedation, Sedation, Deep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Tripler Army Medical CenterUS federal agency
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Posted 11 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. Animal data shows significant alterations in steroid intermediates under anesthesia regardless of the procedure performed. Prior studies in children show general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the effects of moderate and deep sedation on cortisol levels during different types of procedures are unknown. General medical practice varies considerably among providers; some provide stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive and invasive procedures for patients with known adrenal insufficiency, but the doses given vary considerably. Others provide stress dosing only for the most invasive procedures in this population of patients. Currently there is no published normative data on changes in cortisol levels under moderate and deep sedation in adrenally sufficient children, so the normal response we are trying to mimic is unknown.
We propose to measure salivary cortisol levels prospectively in adrenally sufficient children undergoing moderate and deep sedation to determine the normal cortisol response to the stress of sedation for both invasive and non-invasive procedures.
Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI, echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy) to determine what the normal cortisol response is to the stress of sedation during these procedures using various anesthetic agents.
The primary outcome variable will be to determine peak salivary cortisol measurements during non-invasive and invasive procedures under different levels of sedation using various anesthetic agents, and correlate these with known norms in children to determine if the patient's hypothalamic-pituitary-adrenal axis is under stress.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate Sedation | – | –Children undergoing moderate sedation for procedures. |
| Deep Sedation | – | –Children undergoing deep sedation for procedures. |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Male and female military health care beneficiaries ages 3 months to 18 years of age presenting to the Tripler Army Medical Center pediatric sedation uni twho do not have any diagnosis consistent with or concerning for adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
Key inclusion criteria (3 listed)
- Child presenting for routine sedation to the TAMC Pediatric Sedation Center.
- Age 3 months to 18 years of age.
- If female age 12 or greater OR menstruating, must not be pregnant.
Key exclusion criteria (3 listed)
- Must not have the diagnosis of adrenal insufficiency or any concerns for possible adrenal insufficiency, to include recent tapering of exogenous steroids in the last 6 months.
- Current treatment with oral steroids or has been on oral steroids in the last 3 months.
- The use of regular inhaled corticosteroids for asthma controller treatment or intranasal steroids for allergic rhinitis is specifically NOT an exclusion criteria.
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
Change From Baseline to Peak Salivary Cortisol Level
Time frame: Baseline, then every 30 minutes, and at end of procedure
Salivary cortisol will be measured prior to the sedated procedure before any intravenous lines or other stress occurs, and then every 30 minutes into the sedated procedure while the patient is being routinely suctioned. Salivary cortisol will also be measured at the end of the procedure and 30 minutes post procedure (recovery). Because many different types of procedures are performed (imaging, endoscopy, surgical) the end times of the procedures will vary for each patient. The investigators will calculate a relative change from baseline for salivary cortisol levels by comparing the peak to baseline recorded level.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22855336Hsu AA, von Elten K, Chan D, Flynn T, Walker K, Barnhill J, Naun C, Pedersen AM, Ponaman M, Fredericks GJ, Crudo DF, Pinsker JE. Characterization of the cortisol stress response to sedation and anesthesia in children. J Clin Endocrinol Metab. 2012 Oct;97(10):E1830-5. doi: 10.1210/jc.2012-1499. Epub 2012 Aug 1.
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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.
Angela Hsu, MD principal investigator
Tripler Army Medical Center
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 Adrenal Insufficiency, run by Tripler Army Medical Center 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 3 inclusion and 3 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 11 Mar 2013. 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?
Yes. Results are posted in the registry (first posted 11 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Peak Salivary Cortisol Level (time frame: Baseline, then every 30 minutes, and at end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265966, which also lists 1 linked publication.
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 11 Mar 2013.