Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-03-04 @ 7:32 AM
Study NCT ID:
NCT01456533
Status:
COMPLETED
Last Update Posted:
2015-12-02
First Post:
2011-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D006955', 'term': 'Hypernatremia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-30', 'studyFirstSubmitDate': '2011-09-30', 'studyFirstSubmitQcDate': '2011-10-18', 'lastUpdatePostDateStruct': {'date': '2015-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'diagnostic accuracy of copeptin within hospital stay', 'timeFrame': 'participants will be followed for up to 1 year', 'description': 'diagnostic accuracy will be determined by receiver operated curve (ROC) analysis. The study is powered to detect a difference of copeptin levels between patients with partial central diabetes insipidus (DI) and patients with primary polydipsia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyponatremia', 'hypernatremia'], 'conditions': ['Hyponatremia', 'Hypernatremia']}, 'referencesModule': {'references': [{'pmid': '30462243', 'type': 'DERIVED', 'citation': 'Sailer CO, Winzeler B, Nigro N, Bernasconi L, Mueller B, Christ-Crain M. Influence of Outdoor Temperature and Relative Humidity on Incidence and Etiology of Hyponatremia. J Clin Endocrinol Metab. 2019 Apr 1;104(4):1304-1312. doi: 10.1210/jc.2018-01507.'}, {'pmid': '29422070', 'type': 'DERIVED', 'citation': 'Nigro N, Winzeler B, Suter-Widmer I, Schuetz P, Arici B, Bally M, Refardt J, Betz M, Gashi G, Urwyler SA, Burget L, Blum CA, Bock A, Huber A, Muller B, Christ-Crain M. Copeptin levels and commonly used laboratory parameters in hospitalised patients with severe hypernatraemia - the "Co-MED study". Crit Care. 2018 Feb 9;22(1):33. doi: 10.1186/s13054-018-1955-7.'}]}, 'descriptionModule': {'briefSummary': 'Background: Hypo- and hypernatremia are common in hospitalized patients. The differential diagnosis of dysnatremia is challenging.\n\nOsmotically inadequate secretion of antidiuretic hormone (ADH) is the predominant mechanism in most dysnatremic disorders. ADH measurement is cumbersome. It is derived from a larger precursor peptide along with copeptin, which is a more stable peptide directly mirroring the production of ADH.\n\nObjective: To evaluate the additional value of copeptin to improve a currently used algorithm in the differential diagnosis of (A) severe hypoosmolar hypo- and (B) severe hypernatremia.\n\nDesign: Prospective observational study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized patients with severe hypo or hypernatremia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hyponatremia \\<125 or hypernatremia \\>155 mmol/L\n\nExclusion Criteria:\n\n* no informed consent'}, 'identificationModule': {'nctId': 'NCT01456533', 'acronym': 'COMED', 'briefTitle': 'Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Copeptin in the Differential Diagnosis of Dysnatremia in Hospitalized Patients', 'orgStudyIdInfo': {'id': 'COMED Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hospitalized patients', 'description': 'hospitalized patients with hyponatremia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'state': 'Basel', 'country': 'Switzerland', 'facility': 'Mirjam Christ-Crain', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'city': 'Aarau', 'state': 'Canton of Aargau', 'country': 'Switzerland', 'facility': 'Beat Müller', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}, {'name': 'Beat Müller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kantonsspital Aarau, University Hospital Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kantonsspital Aarau', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}