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

Infant Morbidity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839812
• Other study ID #: 08-001638
• Status: Completed
• Phase: Phase 1
• First received: April 22, 2013
• Last updated: June 13, 2014
• Start date: March 2009
• Est. completion date: June 2013

Study information

• Verified date: June 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 365 Days

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Adrenal Cortex Diseases
• Infant Morbidity

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 hours after surgery	No