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Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery

Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01839812
Enrollment
35
Registered
2013-04-25
Start date
2009-03-31
Completion date
2013-06-30
Last updated
2014-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Cortex Diseases, Infant Morbidity

Keywords

Cardiopulmonary bypass, Cortisol, Dexamethasone

Brief 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). 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).

Interventions

A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 365 Days
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cortisol level24 hours after surgeryPrimary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026