- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01839812
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55903
- Mayo Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- less than 365 days of age
- Congenital cardiac surgery that requires cardiopulmonary bypass
Exclusion Criteria:
- Corticosteroids within 24 hours prior to enrollment
- Less than 36 weeks gestational age at time of surgery
- pre-operative mechanical circulatory support (ECMO)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: cosyntropin stimulation test
All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response.
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A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortisol level
Time Frame: 24 hours after surgery
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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.
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24 hours after surgery
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sheri S Crow, MD,MS, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Adrenal Gland Diseases
- Adrenal Cortex Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cosyntropin
- Adrenocorticotropic Hormone
- Melanocyte-Stimulating Hormones
- beta-Endorphin
Other Study ID Numbers
- 08-001638
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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