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Adrenal Insufficiency clinical trials

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NCT ID: NCT01371526 Completed - Adrenal Failure Clinical Trials

Revival of Stem Cells in Addison's Study

RoSA
Start date: September 2010
Phase: Phase 4
Study type: Interventional

Autoimmune Addison's disease (AAD) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. Untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. A key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (ACTH) concentration. This study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune Addison's disease (AAD) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (ACSCs) (1,2). Using daily subcutaneous ACTH, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of ACSC activity is a realistic possibility.

NCT ID: NCT01265966 Completed - Clinical trials for Adrenal Insufficiency

Cortisol Response to Moderate and Deep Sedation in Children

Start date: December 2010
Phase: N/A
Study type: Observational

Currently, it is unknown whether sedation itself induces a rise in serum cortisol levels or if cortisol levels rise under only the most invasive of procedures, regardless of the type of anesthetic agent used. Animal data shows significant alterations in steroid intermediates under anesthesia regardless of the procedure performed. Prior studies in children show general anesthesia and even epidural anesthesia can cause a rise in serum cortisol, but the effects of moderate and deep sedation on cortisol levels during different types of procedures are unknown. General medical practice varies considerably among providers; some provide stress dosing (extra and sometimes high doses of steroids) for sedation for both non-invasive and invasive procedures for patients with known adrenal insufficiency, but the doses given vary considerably. Others provide stress dosing only for the most invasive procedures in this population of patients. Currently there is no published normative data on changes in cortisol levels under moderate and deep sedation in adrenally sufficient children, so the normal response we are trying to mimic is unknown. We propose to measure salivary cortisol levels prospectively in adrenally sufficient children undergoing moderate and deep sedation to determine the normal cortisol response to the stress of sedation for both invasive and non-invasive procedures. Up to 300 adrenally sufficient children will be prospectively recruited to measure salivary cortisol levels during moderate and deep sedation for non-invasive procedures (e.g. MRI, echocardiogram, or other imaging studies), and invasive procedures (e.g. surgery, endoscopy) to determine what the normal cortisol response is to the stress of sedation during these procedures using various anesthetic agents. The primary outcome variable will be to determine peak salivary cortisol measurements during non-invasive and invasive procedures under different levels of sedation using various anesthetic agents, and correlate these with known norms in children to determine if the patient's hypothalamic-pituitary-adrenal axis is under stress.

NCT ID: NCT01184209 Completed - Clinical trials for Adrenal Insufficiency

Prospective Study on the Incidence of Adrenal Crisis in Patients With Chronic Adrenal Insufficiency

Start date: February 2007
Phase: N/A
Study type: Observational

Prospective study to evaluate incidence, causes and potential risk factors for adrenal crisis in patients with chronic adrenal insufficiency.

NCT ID: NCT01093261 Completed - Clinical trials for Traumatic Brain Injury

Corticosteroid Therapy for Glucocorticoid Insufficiency Related to Traumatic Brain Injury

Corti-TC
Start date: August 2010
Phase: Phase 3
Study type: Interventional

Traumatic brained injured (TBI) patients frequently suffered from glucocorticoid insufficiency that is associated with a raise in the rate of pneumonia. In a placebo-controlled, multi-center, double-blinded trial, treatment of glucocorticoid insufficiency (hydrocortisone associated with fludrocortisone) will be assessed for prevention of post trauma pneumonia in a population of severe TBI patients.

NCT ID: NCT01089075 Terminated - Clinical trials for Partial Corticotrope Insufficiency

Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

CSMünchen01
Start date: February 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.

NCT ID: NCT01053754 Terminated - Clinical trials for Adrenocortical Insufficiency

Optimization of the Evaluation of the Adrenal Function After Discontinuation of a Prolonged Therapy With Corticosteroids

Start date: January 2010
Phase: N/A
Study type: Interventional

The study (forward-looking and opened) will concern 70 subjects having had a systemic prolonged treatment with corticosteroids for intestinal chronic inflammatory disease, recruited in the services of gastroenterology and endocrinology of the North Hospital of Marseille (France). The primary objective of the study is to estimate a new test, the "long" synacthen stimulation test, using an IM injection of 1 mg of delate synacthen, with regard to the definitive standard. Indeed, this long test could be realized in ambulatory conditions, and turn out more contributory than the definitive standard to estimate the capacities of answer of the adrenal glands in front of a prolonged stress, as it is the case during a surgical procedure for example. The secondary objectives are: 1) to determine the relation between the value of basal cortisol and the peak of stimulation of cortisol during short and long tests. This could allow to clarify better the conditions in which it is absolutely necessary to realize a dynamic test, 2) to determine the relation between cortisol assay in the plasma and in the saliva. The sample of saliva is simple and non-invasive, and presents the advantage to be able to be realized in ambulatory conditions and by the patient himself. The cortisonic withdrawal syndrome is another complication which can arise when a prolonged corticosteroid therapy is discontinued. Clinically, it looks like a chronic adrenocortical insufficiency, but with normal ranges of plasma cortisol. It is probably in touch with a physical dependence to the taking of above physiological doses of GC over a long period. Its physiopathology remains badly known, but could bring in a deficit of secretion of DHEA-S (dehydro-epiandrosterone sulphate), another hormone secreted by the adrenal glands. One of the secondary objectives of the study will consist in informing the variations of DHEA-S after a prolonged corticotherapy, in the basal state and after stimulation by the long synacthen stimulation test.

NCT ID: NCT01052207 Completed - Critical Illness Clinical Trials

Pilot Study Assessing Oxidative Stress in Children

OxStress
Start date: February 2010
Phase: N/A
Study type: Observational

Role fo oxidative stress in adrenal insufficiency has not been studied. The degree of oxidative stress and it's role in pediatric critical illness is unknown. Potential for significant alterations to many of thew body's regulatory pathways may result from severe oxidative stress. Further is needed to delineate what if any role oxidative stress may play

NCT ID: NCT01045876 Withdrawn - Clinical trials for Adrenal Insufficiency

The Effect of Dexamethasone on Cortisol Levels in Patients Undergoing Thyroid Surgery

Start date: May 2010
Phase: Phase 4
Study type: Interventional

Many drugs are used to prevent nausea and vomiting and pain after surgery. In this study the investigators will be looking at a drug, dexamethasone, which is commonly used to prevent nausea and vomiting and pain after surgery but has other side effects. Dexamethasone is a man-made drug that is commonly used during surgery but also can affect naturally occuring hormones. In this study the investigators will be looking at dexamethasone's effect on a number of naturally occuring hormones over a twenty four hour period after thyroid surgery. The investigators hypothesize that plasma cortisol levels will be decreased following administration of dexamethasone.

NCT ID: NCT00975078 Completed - Clinical trials for Adrenal Gland Hypofunction

Test Predicting Adrenal Insufficiency in Volunteers Under Prednisone Treatment

Start date: May 2009
Phase: Phase 4
Study type: Interventional

Suppression of the adrenal function is a common, potentially dangerous and unpredictable consequence of short term high dose glucocorticoid treatment. Identification of patients at risk would be of high clinical importance. The investigators hypothesized that the dexamethasone-suppression-test predicts the subsequent development of corticosteroid induced adrenal insufficiency.

NCT ID: NCT00974337 Completed - Clinical trials for Adrenal Insufficiency

Relative Adrenal Insufficiency in Preterm Very Low Birth Weight Infants With Shock

Start date: March 2008
Phase: N/A
Study type: Observational

The objective of this study is to estimate the prevalence of relative adrenal insufficiency in preterm very low birth weight infants with and without shock.