Completed

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

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What is being tested

Cosyntropin

Drug
Who is being recruted

Adrenal Gland Diseases

+ Endocrine System Diseases

+ Adrenal Cortex Diseases

+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Phase 1
Interventional
Study Start: March 2009
See protocol details

Summary

Principal SponsorMayo Clinic
Last updated: June 16, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2009

Actual date on which the first participant was enrolled.

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).

NCT01839812
Principal SponsorMayo Clinic
Last updated: June 16, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Adrenal Gland DiseasesEndocrine System DiseasesAdrenal Cortex Diseases

Criteria

2 inclusion criteria required to participate
Congenital cardiac surgery that requires cardiopulmonary bypass
less than 365 days of age
3 exclusion criteria prevent from participating
Corticosteroids within 24 hours prior to enrollment
Less than 36 weeks gestational age at time of surgery
pre-operative mechanical circulatory support (ECMO)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Mayo Clinic

Rochester, United StatesOpen Mayo Clinic in Google Maps
CompletedOne Study Center