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Patients with adrenal insufficiency are at risk to suffer from life threatening adrenal crisis. The aim of this trial was to reevaluate the frequency of adrenal crisis and risk factors for crisis within a prospective study (six-years follow-up of a former prospective study).
Despite established hormone replacement therapy, patients with chronic adrenal insufficiency are at risk of suffering from life threatening adrenal crisis with a considerable mortality. A former prospective study revealed a frequency of about 8 adrenal crisis/ 100 patient years and a crisis associated mortality of 0.5 per 100 patient years for patients; furthermore, patients with a previous adrenal crisis were at higher risk of crisis. The aim of the current trial was to reevaluate the frequency of adrenal crisis and risk factors by contacting the patients of the initial prospective study (see above) within a six-years follow-up. Patients are contacted by questionnaire and additionally by phone (in case of an adrenal crisis or implausible statements).
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adrenal crisis | Evaluation of the frequency of adrenal crisis / number of adrenal crisis per patient years (adrenal crisis/100 patient years). Documentation of the number of adrenal crisis (within a follow-up-period of 6 years) of all participating patients. | six years |
| Measure | Description | Time Frame |
|---|---|---|
| Risk factors | Identification of risk factors / confirmation of risk factors observed in former trials (previous adrenal crisis, female sex, diabetes insipidus) for adrenal crisis. Calculation of odds ratios. | six years |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients with primary or secondary adrenal insufficiency that already participated in a former prospective study investigating adrenal crisis (Hahner et. al 2015).
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25419882 | Background | Hahner S, Spinnler C, Fassnacht M, Burger-Stritt S, Lang K, Milovanovic D, Beuschlein F, Willenberg HS, Quinkler M, Allolio B. High incidence of adrenal crisis in educated patients with chronic adrenal insufficiency: a prospective study. J Clin Endocrinol Metab. 2015 Feb;100(2):407-16. doi: 10.1210/jc.2014-3191. Epub 2014 Nov 24. | |
| 19955259 |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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| Hahner S, Loeffler M, Bleicken B, Drechsler C, Milovanovic D, Fassnacht M, Ventz M, Quinkler M, Allolio B. Epidemiology of adrenal crisis in chronic adrenal insufficiency: the need for new prevention strategies. Eur J Endocrinol. 2010 Mar;162(3):597-602. doi: 10.1530/EJE-09-0884. Epub 2009 Dec 2. |
| 26208266 | Background | Smans LC, Van der Valk ES, Hermus AR, Zelissen PM. Incidence of adrenal crisis in patients with adrenal insufficiency. Clin Endocrinol (Oxf). 2016 Jan;84(1):17-22. doi: 10.1111/cen.12865. Epub 2015 Aug 27. |
| 19776201 | Background | White K, Arlt W. Adrenal crisis in treated Addison's disease: a predictable but under-managed event. Eur J Endocrinol. 2010 Jan;162(1):115-20. doi: 10.1530/EJE-09-0559. Epub 2009 Sep 23. |