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Status:

COMPLETED

Adrenal Function in Critical Illness

Lead Sponsor:

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

Conditions:

Adrenal Insufficiency

Eligibility:

All Genders

15-65 years

Brief Summary

An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue resistance to glucocort...

Detailed Description

An appropriate hypothalamic-pituitary-adrenal (HPA) axis response is required to survive critical illness. Primary adrenal insufficiency, relative adrenal insufficiency, tissue resistance to glucocort...

Eligibility Criteria

Inclusion

  • 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 greater than 70 percent
  • Cardiac Index greater than 3.5L min(-1) M(-23)
  • EXCLUSION CRITERIA:
  • 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:
  • Documented longstanding primary or secondary adrenal insufficiency
  • EXCLUSION CRITERIA:
  • Pregnancy
  • TRANSIENT ADRENAL INSUFFICIENCY COMPONENT:
  • INCLUSION CRITERIA:
  • Recent uncomplicated successful transsphemoidal surgery for Cushing s disease with serum cortisol level less than 5 micro g/dl
  • TRANSIENT ADRENAL INSUFFICIENCY COMPONENT:
  • EXCLUSION CRITERIA:
  • Supra physiologic dosing of glucocorticoids as a treatment for another underlying medical disorder or surgical complication
  • Pregnancy
  • CIRRHOSIS AND NEPHROTIC SYNDROME COMPONENT:
  • Adults aged at least 18 years will be recruited.
  • CIRRHOSIS
  • INCLUSION CRITERIA:
  • Participation in an active NIDDK protocol entitled: Evaluation of patients with liver disease (91-DK-0214), with evidence of chronic liver disease
  • Agreement from the hepatologist PI that the patient may participate in this protocol.
  • Child-Pugh class A or B cirrhosis secondary to viral hepatitis
  • Absence of other significant medical illnesses that might interfere with prolonged follow-up evaluation
  • Normal renal function (creatinine clearance estimated as \> 60 ml/min by the Modified Diet in Renal Disease (MDRD) equation and reported through our Clinical Research Information System (CRIS)).
  • EXCLUSION CRITERIA:
  • History of the use of glucocorticoid therapy or medications that are known to interfere with HPA axis function within the past 6 months
  • Current symptoms of adrenal insufficiency (nausea, vomiting, weight loss, lightheadedness, unusual fatigue, salt craving, etc.).
  • Evidence of moderate-severe medical illness attributable to obstructive sleep apnea, heart or pulmonary failure, or active malignancy will be excluded.
  • Pregnancy
  • Known or anticipated blood withdrawal within 6 weeks that exceeds the NIH guidelines of 450 ml/six weeks in adults.
  • NEPHROTIC SYNDROME:
  • INCLUSION CRITERIA:
  • Participation in one of three active NIDDK protocols entitled: Rituximab plus cyclosporine in idiopathic membranous nephropathy (09-DK-0223), the Nephrotic Syndrome Study Network (Neptune) (11-DK-0023), or Pathogenesis of Glomerulosclerosis Study (94-DK-0127) with previously documented proteinuria \>3.5g/day for 2 months or more or protein/creatinine ratio of 2.0 g/g on at least 2 occasions
  • Agreement from the nephrologist PI that the patient may participate in this protocol. Estimated GFR greater than or equal to 30 ml/min based on the MDRD equation and reported through CRIS.
  • Normal liver function as defined by normal liver function tests and no known history of liver disease.
  • EXCLUSION CRITERIA:
  • History of the use of glucocorticoid therapy or medications that are known to interfere with HPA axis function within the past 6 months
  • Current symptoms of adrenal insufficiency (nausea, vomiting, weight loss, lightheadedness, unusual fatigue, salt craving, etc.).
  • Evidence of moderate-severe medical illness attributable to obstructive sleep apnea, heart or pulmonary failure, or active malignancy will be excluded.
  • Pregnancy
  • Known or anticipated blood withdrawal within 6 weeks that exceeds the NIH guidelines of 450 ml/six weeks in adults.

Exclusion

    Key Trial Info

    Start Date :

    November 12 2004

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    225 Patients enrolled

    Trial Details

    Trial ID

    NCT00156767

    Start Date

    November 12 2004

    Last Update

    January 8 2026

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892