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NCT03368066 · ClinicalTrials.gov registry record · Phase 3
Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?
A Phase 3 study, sponsored by University of Virginia.
- Completed
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
NCT03368066 is a Phase 3 study that has completed, run by University of Virginia. The registered enrollment target is 100 participants.
The verdict
NCT03368066, a Phase 3 study, has completed, sponsored by University of Virginia.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
Study Summary
The hepatoadrenal syndrome has been well described in the literature and is known to be associated with poorer outcomes in both stable and critically ill cirrhotic patients. In chronic liver disease, adrenal (and more specifically cortisol) insufficiency is thought to be a byproduct of altered lipid metabolism that results in decreased HDL production and thus decreased delivery of cholesterol to the adrenal for subsequent corticosteroid production. 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. The investigators seek to quantify this LCAT deficiency in a cohort of cirrhotic patients and demonstrate its association with various abnormal physiologies associated with chronic liver disease, including spur cell anemia, low HDL levels, and adrenal insufficiency. Hospitalized cirrhotic patients at UVA that meet study eligibility criteria will be approached by a member of the study team to obtain consent for participation. If a patient agrees to become a study subject, they will have an approximate total of 35ml of blood drawn the following morning. Lab tests to be performed include: peripheral blood smear, lipid panel, free cortisol, cortisol binding globulin, serum cholesterol esters (surrogate for LCAT enzyme activity), and a standard-dose cortisol stimulation test. The latter involves blood drawn with the initial collection, administration of an intravenous 250mcg dose of synthetic ACTH, and then repeat small-volume blood draws at 30 minutes and 60 minutes later. Subjects will be classified as adrenally sufficient or insufficient on the basis of as standard-dose cortisol stimulation test. Variables of interest for comparison between the groups include MELD score, Child-Turcotte-Pugh (CTP) classification, high-density lipoprotein (HDL) levels, presenc
Interventions
- DRUG Cosyntropin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2018-01-29 |
| Est. Completion | 2019-03-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03368066
The ClinicalTrials.gov registry entry for NCT03368066 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cosyntropin is the first listed.
NCT03368066 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03368066 about?
NCT03368066 is a clinical study titled "Is Adrenal Insufficiency Under-diagnosed in Hospitalized Cirrhosis Patients?". The hepatoadrenal syndrome has been well described in the literature and is known to be associated with poorer outcomes in both stable and critically ill cirrhotic patients. In chronic liver disease, adrenal (and more specifically cortisol) insufficiency is thought to be a byproduct of altered lipid...
What is the current status of trial NCT03368066?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2018-01-29. Estimated completion is 2019-03-12.
What interventions are being tested in trial NCT03368066?
The interventions under investigation include: Cosyntropin (DRUG).
Who is sponsoring clinical trial NCT03368066?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
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