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

NCTNCT01839812Other id08-001638

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 35 participants (actual)
Sponsor: Mayo Clinic · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Mar 2009
Primary completion: Jun 2013
Completion: Jun 2013
First posted: 25 Apr 2013 (estimated)
Last update posted: 16 Jun 2014 (estimated)
Conditions: Adrenal Cortex Diseases · Infant Morbidity

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011201220132014

Ph 1
Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
NCT01839812
Mar 2009 to Jun 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

CosyntropinDrug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Cortisol level
Time frame · 24 hours after surgery
Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: up to 365 Days
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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)

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