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NCT00156767 · ClinicalTrials.gov registry record

Adrenal Function in Critical Illness

A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Completed
Registry status
225
Enrollment target

NCT00156767: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

NCT00156767 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 225 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00156767 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

COMPLETED
Registry status
225 participants
Enrollment target

Study Summary

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. ...

Primary Outcome

cortisol increase

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2004-11-12

What the finished NCT00156767 record still lists

NCT00156767 is an observational study that tracks outcomes without assigning an intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT00156767 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00156767 about?

NCT00156767 is a clinical study titled "Adrenal Function in Critical Illness". 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 a...

What is the current status of trial NCT00156767?

This trial is currently completed. The enrollment target is 225 participants. The study started on 2004-11-12.

Who is sponsoring clinical trial NCT00156767?

This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT00156767, the US trial registry maintained by the National Library of Medicine. NCT00156767 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.