Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT03426332
Status:
COMPLETED
Last Update Posted:
2018-02-08
First Post:
2018-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Management of Adrenal Emergency in Germany
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000309', 'term': 'Adrenal Insufficiency'}], 'ancestors': [{'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2018-01-18', 'studyFirstSubmitQcDate': '2018-02-01', 'lastUpdatePostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median time from contacting a medical professional to arrival of professional medical help', 'timeFrame': '6-36 months', 'description': '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.\n\nThe 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.'}, {'measure': 'Median time from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional', 'timeFrame': '6-36 months', 'description': 'Evaluation of the median time (in minutes) from showing the emergency card (by a patient) to glucocorticoid-injection by a medical professional.\n\nThe 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.'}, {'measure': 'Median time from the beginning of symptoms to glucocorticoid-injection', 'timeFrame': '6-36 months', 'description': 'Evaluation of the median time (in minutes) from the beginning of symptoms to glucocorticoid-injection during an (adrenal) emergency.\n\nThe 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.'}, {'measure': 'Duration of hospitalisation (number of days at a hospital)', 'timeFrame': '6-36 months', 'description': 'Evaluation of the duration of hospitalisation (number of days at a hospital) due to an adrenal emergency.\n\nThe 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.'}, {'measure': 'Number of patients that received an intramuscular glucocorticoid-injection', 'timeFrame': '6-36 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Cause of the adrenal emergency', 'timeFrame': '6-36 months', 'description': '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.'}, {'measure': 'Median time from the beginning of symptoms to oral dose adjustment (glucocorticoids) during an adrenal emergency', 'timeFrame': '6-36 months', 'description': 'Evaluation of the median time (in minutes) from the beginning of symptoms to oral dose adjustment (glucocorticoids).\n\nThe 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.'}, {'measure': 'Median time from the beginning of symptoms to contacting a medical professional', 'timeFrame': '6-36 months', 'description': 'Evaluation of the median time (in minutes) from the beginning of symptoms to contacting a medical professional during an adrenal emergency.\n\nThe 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.'}, {'measure': 'Symptoms of the adrenal emergency', 'timeFrame': '6-36 months', 'description': '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.'}, {'measure': 'Median amount of additionally oral ingested glucocorticoids during the adrenal emergency', 'timeFrame': '6-36 months', 'description': 'Evaluation of the median amount of additionally oral ingested glucocorticoids (in mg) during the adrenal emergency.\n\nThe 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adrenal Insufficiency', 'Adrenal crisis', 'Adrenal emergency', 'Glucocorticoid injection'], 'conditions': ['Adrenal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '25419882', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '25200922', 'type': 'BACKGROUND', 'citation': 'Hahner S, Hemmelmann N, Quinkler M, Beuschlein F, Spinnler C, Allolio B. Timelines in the management of adrenal crisis - targets, limits and reality. Clin Endocrinol (Oxf). 2015 Apr;82(4):497-502. doi: 10.1111/cen.12609. Epub 2014 Nov 6.'}, {'pmid': '25288693', 'type': 'BACKGROUND', 'citation': 'Allolio B. Extensive expertise in endocrinology. Adrenal crisis. Eur J Endocrinol. 2015 Mar;172(3):R115-24. doi: 10.1530/EJE-14-0824. Epub 2014 Oct 6.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged ≥18 years with a documented chronic adrenal insufficiency under established corticosteroid replacement therapy.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Documented chronic adrenal insufficiency\n* Established corticosteroid replacement therapy\n* Written informed consent\n\nExclusion Criteria:\n\n\\- Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT03426332', 'acronym': 'MAdEy', 'briefTitle': 'Management of Adrenal Emergency in Germany', 'organization': {'class': 'OTHER', 'fullName': 'Wuerzburg University Hospital'}, 'officialTitle': 'Management of Adrenal Emergency in Germany - a Prospective Multicenter', 'orgStudyIdInfo': {'id': 'MAdEy-Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuerzburg University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Frankfurt, Germany', 'class': 'UNKNOWN'}, {'name': 'Endocrinology in Charlottenburg, Berlin, Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}