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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2013-06-30

Brief Summary

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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.

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Detailed Description

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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

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Adrenal Cortex Diseases Infant Morbidity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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cosyntropin stimulation test

All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response.

Group Type OTHER

Cosyntropin

Intervention Type DRUG

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

Interventions

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Cosyntropin

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

Intervention Type DRUG

Other Intervention Names

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adrenocorticotropic hormone

Eligibility Criteria

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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)

Maximum Eligible Age

365 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No