An observational study in Adrenal Insufficiency, sponsored by Wuerzburg University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Wuerzburg University Hospital · Observational
The management of adrenal crisis is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies requiring parenteral glucocorticoid treatment by a prospective multicenter study in patients with chronic adrenal insufficiency.
Despite established hormone replacement therapy, patients with chronic adrenal insufficiency (AI) are at risk of suffering from adrenal crisis (AC). Further data suggests that the management of AC is often problematic and the time to adequate treatment is frequently delayed.The aim of the study is to evaluate the management of adrenal emergencies (AE) requiring parenteral glucocorticoid (GC) treatment by a prospective multicenter study.
Patients with chronic AI receive a questionnaire on the management of emergency situations, which had to be completed and sent back in case of an emergency requiring parenteral GC administration. Furthermore, patients were contacted by phone in case of a missing response every six months.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
This study's enrollment of 150 is above the median of 85 across 59 observational studies indexed under Adrenal Insufficiency.
Browse Adrenal Insufficiency studies →Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients aged ≥18 years with a documented chronic adrenal insufficiency under established corticosteroid replacement therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No intervention
Median time from contacting a medical professional to arrival of professional medical help
Evaluation of the median time (in minutes) from contacting a medical professional (by the patient) to arrival of professional medical help during an (adrenal) emergency. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional
Evaluation of the median time (in minutes) from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Median time from the beginning of symptoms to glucocorticoid-injection
Evaluation of the median time (in minutes) from the beginning of symptoms to glucocorticoid-injection during an (adrenal) emergency. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Duration of hospitalisation (number of days at a hospital)
Evaluation of the duration of hospitalisation (number of days at a hospital) due to an adrenal emergency. The number of days is documented by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Number of patients that received an intramuscular glucocorticoid-injection
Evaluation of the number of patients that received an intramuscular glucocorticoid-injection (compared to subcutaneous administration) during an adrenal emergency. Documentation by the patients themselves directly after the adrenal emergency.
Time frame: 6-36 months
Cause of the adrenal emergency
Evaluation of the causes of the adrenal emergencies. The causes are documented in a questionnaire by the patients themselves. The number of different causes that are stated by all patients will be evaluated.
Time frame: 6-36 months
Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency
Evaluation of the median time (in minutes) from the beginning of symptoms to oral dose adjustment (glucocorticoids). The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Median time from the beginning of symptoms to contacting a medical professional
Evaluation of the median time (in minutes) from the beginning of symptoms to contacting a medical professional during an adrenal emergency. The time is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
Symptoms of the adrenal emergency
Evaluation of the symptoms during the adrenal emergencies. The symptoms are documented in a questionnaire by the patients themselves. The number of different symptoms that are stated by all patients will be evaluated.
Time frame: 6-36 months
Median amount of additionally oral ingested glucocorticoids during the adrenal emergency
Evaluation of the median amount of additionally oral ingested glucocorticoids (in mg) during the adrenal emergency. The amount of glucocorticoids is documented in a questionnaire by the patients themselves (directly after the adrenal emergency). The data of all patients will be stated as median and range.
Time frame: 6-36 months
No study locations are listed for this record.
Plan to share: Undecided
Ran from Nov 2015 to primary completion in Nov 2017, 24 months.
Of 27 observational studies under Adrenal Insufficiency, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 98. This study's 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital