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

Primary Purpose

Adrenal Cortex Diseases, Infant Morbidity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cosyntropin
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adrenal Cortex Diseases focused on measuring Cardiopulmonary bypass, Cortisol, Dexamethasone

Eligibility Criteria

undefined - 365 Days (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cosyntropin stimulation test

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
June 13, 2014
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT01839812
Brief Title
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Official Title
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Cortex Diseases, Infant Morbidity
Keywords
Cardiopulmonary bypass, Cortisol, Dexamethasone

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cosyntropin stimulation test
Arm Type
Other
Arm Description
All patients enrolled in the study are administered cosyntropin stimulation tests to assess their adrenal response.
Intervention Type
Drug
Intervention Name(s)
Cosyntropin
Other Intervention Name(s)
adrenocorticotropic hormone
Intervention Description
A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.
Primary Outcome Measure Information:
Title
Cortisol level
Description
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.
Time Frame
24 hours after surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
365 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheri S Crow, MD,MS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55903
Country
United States

12. IPD Sharing Statement

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

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