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

NCT01839812 | Completed Phase 1

• 1 other identifier: 08-001638
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Cortex Diseases; Infant Morbidity

Keywords

Cardiopulmonary bypass; Cortisol; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cosyntropin stimulation test

OTHER

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

Drug: Cosyntropin

Interventions

Cosyntropin DRUG

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

Also known as: adrenocorticotropic hormone

cosyntropin stimulation test

Eligibility Criteria

• Age: Up to 365 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• less than 365 days of age
• Congenital cardiac surgery that requires cardiopulmonary bypass

You may not qualify if:

• Corticosteroids within 24 hours prior to enrollment
• Less than 36 weeks gestational age at time of surgery
• pre-operative mechanical circulatory support (ECMO)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55903, United States

Location

MeSH Terms

Conditions

Adrenal Cortex Diseases

Interventions

Cosyntropin; Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Sheri S Crow, MD,MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 25, 2013
• Study Start: March 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

US (1)