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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT01839812

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adrenal Cortex Diseases Infant Morbidity	Drug: Cosyntropin	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

35 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: cosyntropin stimulation test All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response.	Drug: Cosyntropin A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response. Other Names: adrenocorticotropic hormone

Arm

Intervention/Treatment

Other: cosyntropin stimulation test

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

Drug: Cosyntropin

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

Other Names:

adrenocorticotropic hormone

Outcome Measures

Primary Outcome Measures

Cortisol level [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.