Adrenal Cortex DiseasesPhase 1NCT01839812
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
A Phase 1 study testing Cosyntropin in people with Adrenal Cortex Diseases and Infant Morbidity, run by Mayo Clinic at 1 site in United States.
Trial summary
Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). Read more about this study
- Who is it for?
- Ages Up to 365 days
- Conditions the study is for
- Adrenal Cortex Diseases, Infant Morbidity
- What is being tested?
- Cosyntropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Jun 2013
- Phase
- Phase 1
- 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 Up to 365 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- less than 365 days of age
- Congenital cardiac surgery that requires cardiopulmonary bypass
Who cannot join
- Corticosteroids within 24 hours prior to enrollment
- Less than 36 weeks gestational age at time of surgery
- pre-operative mechanical circulatory support (ECMO)
Trial locations and contacts
1 site in 1 country.
About this study
Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.
Read the detailed description
We conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery.
Blood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-CPB/pre-MUF, 3) Intensive care unit (ICU) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. At each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, ACTH, Interleukin (IL) 10, IL 8, and IL 6. In addition, the innate stress response was evaluated with a cosyntropin stimulation test. Each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), ICU arrival (time 3), and 24 hours after ICU arrival (time 7). Cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).
- Conditions
- Adrenal Cortex Diseases, Infant Morbidity
- Being tested
- Cosyntropin
- Keywords
- Cardiopulmonary bypass, Cortisol, Dexamethasone
- Medical subject headings
- Adrenal Cortex Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosyntropinDrug
Also called adrenocorticotropic hormone
A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.
| Study group | Role | What they receive |
|---|---|---|
| cosyntropin stimulation test | Other | All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response. Receives: Drug: Cosyntropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol level
Primary outcome measure is the cortisol level for each patient at 7 time points throughout the operation and first 24 post-operative hours. Dexamethasone level of the patient is compared with the cortisol level.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startMar 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal Cortex DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri Crow, M.D., Mayo Clinic
- Investigators
- Sheri S Crow, MD,MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01839812
- Sponsor's protocol ID
- 08-001638
- Status last verified
- Jun 2014
- First submitted
- 22 Apr 2013
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01839812
- Acronym / sponsor ID
- 08-001638
- Conditions
- Adrenal Cortex Diseases, Infant Morbidity
- Keywords
- Cardiopulmonary bypass, Cortisol, Dexamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Apr 2013 (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.
Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.
Detailed description
We conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery.
Blood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-CPB/pre-MUF, 3) Intensive care unit (ICU) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. At each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, ACTH, Interleukin (IL) 10, IL 8, and IL 6. In addition, the innate stress response was evaluated with a cosyntropin stimulation test. Each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), ICU arrival (time 3), and 24 hours after ICU arrival (time 7). Cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cosyntropin stimulation test | Other | Drug: CosyntropinAll patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response. |
Who may qualify
- Ages
- Up to 365 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- less than 365 days of age
- Congenital cardiac surgery that requires cardiopulmonary bypass
Key exclusion criteria (3 listed)
- Corticosteroids within 24 hours prior to enrollment
- Less than 36 weeks gestational age at time of surgery
- pre-operative mechanical circulatory support (ECMO)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CosyntropinAlso: adrenocorticotropic hormoneA cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response. | Drug | cosyntropin stimulation test |
Primary outcome
Cortisol level
Time frame: 24 hours after surgery
Primary outcome measure is the cortisol level for each patient at 7 time points throughout the operation and first 24 post-operative hours. Dexamethasone level of the patient is compared with the cortisol level.
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 16 Jun 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.
Sheri S Crow, MD,MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cosyntropin in people with Adrenal Cortex Diseases and Infant Morbidity, run by Mayo Clinic 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 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 16 Jun 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cortisol level (time frame: 24 hours after surgery). 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 16 Jun 2014.