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

Completed · Phase 1

Conditions studied: Adrenal Cortex Diseases, Infant Morbidity

In brief

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.

Key facts

Study ID

NCT01839812

Run by

Mayo Clinic

People needed

35

Starts

2009-03-01

Expected to finish

2013-06-01

Last updated by the study team

2014-06-16

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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