Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?

Plain-language guide to NCT03368066: phase 3 interventional trial of Cosyntropin, anemia, 100 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT03368066
Phase: phase 3
Status: completed
Start: 2018-01-29
Completion (planned or actual): 2019-03-12
Participants: 100 (actual)
Design: na, open label (everyone knows who gets what), diagnostic
Conditions studied: Adrenal Insufficiency; Cirrhosis; Spur Cell Anemia; Lecithin Acyltransferase Deficiency
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Cosyntropin for anemia.

Studies to date have implicated lecithin-cholesterol acetyltransferase (LCAT) as the key enzyme which is deficient in some cirrhotic patients, leading to an impaired ability to esterify cholesterol and thus a loss of normal cellular functioning and membrane stability.

It had 1 arm (groups): Hospitalized cirrhosis patients (experimental).

Administration of cortisol stimulation test to assess for presence or absence of adrenal insufficiency.

The registry classes the interventions as drug.

Who Took Part

100 actual participants took part.

It was open to people of any sex aged from 18 years up to 110 years.

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

Examples of who could join: Age \>=18 years. Diagnosis of cirrhosis. Admission to hospital.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: age \< 18 years; prior enrollment in study (i.e. readmission); prednisone or hydrocortisone use in last 24 hours.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Cosyntropin study: the anemia participants and staff both knew the treatment.

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

It started in 2018-01-29 with completion listed for 2019-03-12.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: Number of Participants With Cholesterol Esterification Deficiency (time frame: 24 hours). Number of Participants With Spur Cell Anemia (time frame: 24 hours). Participant Transplant-Free Survival (time frame: 6 months).

It also tracked 8 secondary outcomes, for example Number of Participants With Relative Adrenal Insufficiency (RAI), Number of Participants With Low Free Cortisol, Number of Participants Who Received Liver Transplantation at 90 Days and Number of Participants Who Received Liver Transplantation at 6 Months.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Cosyntropin in 100 people with anemia.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cosyntropin compound page, Anemia research.

Our Notes on the Compound

Cosyntropin: A synthetic 24-amino-acid fragment of ACTH (also tetracosactide, Synacthen) used mainly in the adrenal stimulation test.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.