Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
225 participants
OBSERVATIONAL
2004-11-12
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Bone Marrow Transplant
Patients enrolled in an NCI protocols for bone marrow transplant for breast cancer using prednisone treatment.
No interventions assigned to this group
Cirrhosis
Adults on NIDDK protocol 91-DK-0213 with evidence of chronic liver disease with class A or B cirrhosis secondary to viral hepatitis
No interventions assigned to this group
Critical Care
Patients with a diagnosis of sepsis by the primary clinical provider in the Emergency room of ICU
No interventions assigned to this group
Healthy Volunteer
Healthy adult volunteers
No interventions assigned to this group
Known Adrenal Insufficiency
patients with known diagnosis of Adrenal Insufficiency
No interventions assigned to this group
Nephrotic Syndrome
Adults enrolled in NIDDK protocols with diagnosis of nephrotic syndrome
No interventions assigned to this group
Post Surgical Treatment for Cushings
Patients with transient adrenal insufficiency secondary to successful surgical treatment of cushing's syndrome
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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)
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.
Adults aged at least 18 years will be recruited.
Documented longstanding primary or secondary adrenal insufficiency
Recent uncomplicated successful transsphemoidal surgery for Cushing s disease with serum cortisol level less than 5 micro g/dl
TRANSIENT ADRENAL INSUFFICIENCY COMPONENT:
* 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)).
* 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
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:
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)
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:
Pregnancy
TRANSIENT ADRENAL INSUFFICIENCY COMPONENT:
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
* 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:
* 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.
15 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Responsible Party
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Principal Investigators
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Lynnette K Nieman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
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References
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Abraham SB, Abel BS, Sinaii N, Saverino E, Wade M, Nieman LK. Primary vs secondary adrenal insufficiency: ACTH-stimulated aldosterone diagnostic cut-off values by tandem mass spectrometry. Clin Endocrinol (Oxf). 2015 Sep;83(3):308-14. doi: 10.1111/cen.12726. Epub 2015 Mar 20.
Related Links
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NIH Clinical Center Detailed Web Page
Other Identifiers
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05-CH-0013
Identifier Type: -
Identifier Source: secondary_id
050013
Identifier Type: -
Identifier Source: org_study_id