CompletedNot Applicable

Adrenal Function in Critical Illness

United States225 participantsStarted 2004-11-12

Plain-language 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.

Who can participate

Age range15 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* CRITERIA FOR ALL ARMS OF STUDY: Women of reproductive age will also undergo a pregnancy test (urine hCG) prior to starting the testing procedure. If the woman is determined to be pregnant, she will not be able to participate in this study. CRITICAL CARE COMPONENT: INCLUSION CRITERIA: Diagnosis of sepsis by the primary clinical provider in the ICU. Diagnosis of the above is based on diagnostic criteria for sepsis as defined by the 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference as listed below: Infection, documented or suspected, and some of the following: General variables * Fever (core temperature greater than 38.3 C) * Hypothermia (core temperature greater than 36C) * Heart Rate greater than 90 min or greater than 2 SD above the normal value for age * Tachypnea * Altered mental status * Significant edema or positive fluid balance (greater than 20ml/kg over 24 hours) * Hyperglycemia (plasma glucose greater than 120 mg/dl) in the absence of diabetes Inflammatory variables * Leukocytosis (WBC count greater than 12,000 uL) * Leukopenia (WBC count less than 4000 uL) * Normal WBC count with greater than 10 percent immature forms * Plasma C-reactive protein greater than 2 SD above the normal value * Plasma procalcitonin greater than 2 SD above the normal value Hemodynamic variables * Arterial hypotension (SBP less than 90mm Hg, MAP less than 70, or an SBP decrease greater than 40 mm Hg in adults or less than 2 SD below normal for age) * SvO2 …

What they're measuring

Cortisol

Timeframe: after ACTH

Trial details

NCT IDNCT00156767

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeOBSERVATIONAL