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

What Was Tested

In this phase 1 trial, researchers set out to test Cosyntropin for gum disease (periodontal) & oral health.

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.

It had 1 arm (groups): cosyntropin stimulation test (other).

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

The registry classes the interventions as drug.

More on the Plan

The researchers 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.

Who Took Part

Enrollment: 35 actual participants took part.

It was open to people of any sex aged up to 365 Days.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Less than 365 days of age. Congenital cardiac surgery that requires cardiopulmonary bypass.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: corticosteroids within 24 hours prior to enrollment; less than 36 weeks gestational age at time of surgery; pre-operative mechanical circulatory support (ecmo).

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Cosyntropin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2009-03 with completion listed for 2013-06.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Cortisol level (time frame: 24 hours after surgery).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Cosyntropin in 35 people with gum disease (periodontal) & oral health.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cosyntropin compound page, Gum disease (periodontal) & oral health research.