Adrenal InsufficiencyNCT03499990
Study to Investigate Adrenal Crisis (Six-year Follow-up)
An observational study of Adrenal Insufficiency, run by Wuerzburg University Hospital.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Insufficiency
- How many people
- 268 participants
- Where
- No sites listed yet
- Study dates
- 13 Aug 2016to 23 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone)
- Written informed consent
Who cannot join
- Adrenal insufficiency due to adrenocortical carcinoma
- Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment
- Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency
- Age younger than 18 years
About this study
Official title: Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)
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).
Read the detailed description
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).
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal crisis, Risk factors
- Medical subject headings
- Adrenal Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six years
Secondary outcomes (1)
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.
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start13 Aug 2016
- Primary completion23 May 2017
- Study completion23 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499990
- Sponsor's protocol ID
- Adrenalcrisis-6FU
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25419882Hahner 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.
PubMed 19955259Smans 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.
PubMed 26208266White 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.
PubMed 19776201
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Investigate Adrenal Crisis in Patients With Chronic Adrenal Insufficiency (Six-year Follow-up)
- ClinicalTrials.gov ID
- NCT03499990
- Acronym / sponsor ID
- Adrenalcrisis-6FU
- Conditions
- Adrenal Insufficiency
- Keywords
- Adrenal crisis, Risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- 13 Aug 2016 (actual)
- Primary completion
- 23 May 2017 (actual)
- Study completion
- 23 May 2017 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (2 listed)
- Chronic primary or secondary adrenal insufficiency; hormone replacement therapy with glucocorticoids (hydrocortisone, cortisone acetat, prednisone or prednisolone)
- Written informed consent
Key exclusion criteria (4 listed)
- Adrenal insufficiency due to adrenocortical carcinoma
- Adrenal insufficiency due to long-term pharmacological glucocorticoid treatment
- Glucocorticoid doses above 7.5 mg prednisolone equivalent for other reasons than adrenal insufficiency
- Age younger than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of adrenal crisis
Time frame: six years
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.
1 secondary outcome
Risk factors
Time frame: six years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 25419882Hahner 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.
- Background: PubMed 19955259Hahner 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.
- Background: PubMed 26208266Smans 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.
- Background: PubMed 19776201White 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Insufficiency, run by Wuerzburg University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adrenal crisis (time frame: six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03499990, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.