Adrenal Function in Critical Illness
Completed
Conditions studied: Adrenal Insufficiency
In brief
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.
Key facts
- Study ID
- NCT00156767
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 225
- Starts
- 2004-11-12
- Last updated by the study team
- 2026-07-28
Who can join
Age: 15 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 greater than 70 percent
- Cardiac Index greater than 3.5L min(-1) M(-23)
You may not qualify if…
- Pregnancy
- Age less than 15 years at the Clinical Center; age less than 18 years at Georgetown or Suburban Hospitals
- On glucocorticoids or megace within two weeks of admission unless using more than one of the following medications, patients taking inhaled corticosteriods (less than 1.5 mg/day budesonide, beclomethasone dipropionate and triamcinolone acetonide and less thab 0.75 mg/day for fluticasone propionate) or intranasal corticosteriods will not be excluded.
- Patients who have received chronic steroid suppressive medications, i.e. etomidate, ketoconazole (Patients receiving etomidate for intubation purposes as a one time dose will not be excluded)
- End stage renal or liver disease (creatinine clearance estimated as less than 20 cc/min by the cockcroft-gault equation: (140 - age) times lean body weight (kg)/ pCr (mg/dl) times 72, in patients with stable renal function; patients requiring dialysis; acute or fulminant hepatitis, alcoholic hepatitis, chronic severe hepatitis, severe obstructive hepatitis, severe coagulopathy, extrahepatic manifestations of ESLD, i.e. hypoxia, cardiomyopathy, acute renal failure)
- Known or anticipated blood withdrawal within 6 weeks that exceeds the NIH guidelines of 450 l/six weeks in adults or 7 ml/kg/six weeks in children.
- BONE MARROW TRANSPLANT COMPONENT:
- INCLUSION CRITERIA:
- Participation in a Clinical Center bone marrow transplant protocol for breast cancer (generally Allogeneic Breast Protocol 2: Phase 1 Trial of T cell Exchange with Th2/Tc2 Cells for Allogeneic Stem Cell Transplantation after Reduced Intensity Conditioning for Metastatic Breast Cancer), or for hematologic malignancy (generally either: T-cell depleted, reduced intensity allogeneic stem cell transplant from haploidentical related donors for hematologic malignancies: A sequential dose escalation study of donor Th2/Tc2 cells or Th2, Sirolimus in Allogeneic HSCT.
- Agreement from the oncologist PI that the patient may participate in this protocol.
- EXCLUSION CRITERIA:
- The presence of any contraindication to insulin tolerance testing-e.g.cardiovascular or cerebrovascular disease or any seizure history.
- Pregnancy
- Age less than 15 years
- End stage renal or liver disease as defined under the critical care section
- Known or anticipated blood withdrawal within 6 weeks that exceeds the NIH guidelines of 450 ml/six weeks in adults.
- HEALTHY VOLUNTEER COMPONENT:(Closed to recruitment)
- INCLUSION CRITERIA:
- Adults aged at least 18 years will be recruited.
- EXCLUSION CRITERIA:
- Severe hepatic, renal, cardiac, psychiatric or neurological illnesses
- More than two weeks of oral antifungal or glucocorticoid medications or near daily use of topical glucocorticoids with broken skin. Frequent use of topical antifungal agents will be considered on a case-by-case basis.
- Pregnancy
- KNOWN ADRENAL INSUFFICIENCY COMPONENT:
- INCLUSION CRITERIA:
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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