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Adrenal Function in Critical Illness

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 340 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor New version filed on ClinicalTrials.gov
  2. Minor 49 versions Re-verified since Oct 25, 2024, no change to tracked fieldsv291-v339
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue resistance to glucocorticoids, ACTH deficiency and immune-mediated inhibition of the HPA axis may impair the secretion or action of glucocorticoids in critically ill patients. Adrenal insufficiency is estimated to occur in up to 77% of critically ill patients, but currently, there is no consensus on the diagnostic criteria for adrenal insufficiency in this setting, and standard testing does not discriminate among the aforementioned factors. We will study the incidence and natural history of adrenal insufficiency in critically ill patients to further define adrenal insufficiency and provide data to develop diagnostic tests. Clinical features and outcomes will be correlated with laboratory measurements of hormones, cytokines and glucocorticoid action. Healthy volunteers will undergo cortrosyn tests with measurement of free cortisol levels to develop a normative range for this endpoint. \<TAB\> Previous glucocorticoid use, if prolonged and supraphysiologic, also inhibits the HPA and can result in adrenal insufficiency. Patients with short intermittent courses of glucocorticoid administration have not been studied well, and may also be at risk. To gain further information about this group, patients receiving pulse glucocorticoid doses as part of bone marrow transplant regimens at the Clinical Center will also be studied. ...
Trial Details
NCT Number NCT00156767
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Adrenal Insufficiency
Enrollment 225 participants
Start Date
Updated on ClinicalTrials.gov