Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT02012660
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2013-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Heat Wave and Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}], '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': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28734}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-28', 'studyFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with moderate to severe hyponatremia', 'timeFrame': 'Natremia measured at admission in the ED', 'description': 'Moderate to severe hyponatremia is defined as Sodium blood levels \\< 125 mmol/L'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'December 2011 to August 2013'}, {'measure': 'Hospital length of stay', 'timeFrame': 'December 2011 to August 2013'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyponatremia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to explore the relationship between moderate to severe hyponatremia and heat.', 'detailedDescription': 'We will explore the relationship between heat wave and moderate and severe hyponatremia in a population of adult patients admitted in the emergency department of a primary and tertiary care teaching urban hospital. We will compare the prevalence of hyponatremia between summer and winter periods. We will describe the types of observed hyponatremia and describe the characteristics of the patients suffering of moderate to severe hyponatremia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults admitted to the emergency departement of a primary and tertiary care teaching hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adults (\\> 16 y) with blood natremia measured\n\nExclusion Criteria:\n\n* Patients without measure of natremia in the emergency department'}, 'identificationModule': {'nctId': 'NCT02012660', 'briefTitle': 'Relationship Between Heat Wave and Hyponatremia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Relationship Between Heat Wave and Moderate to Severe Hyponatremia in the Emergency Departement of Primary and Tertiary Care Teaching Hospital.', 'orgStudyIdInfo': {'id': 'SU-051213'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hyponatremia, seasonality', 'description': 'Summer months = June, July, August Winter months = December, January, February', 'interventionNames': ['Other: Seasonality']}], 'interventions': [{'name': 'Seasonality', 'type': 'OTHER', 'otherNames': ['Summer = June, July, August', 'Winter = December, January, February'], 'description': 'The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.', 'armGroupLabels': ['Hyponatremia, seasonality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Geneva University', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}], 'overallOfficials': [{'name': 'Olivier T Rutschmann, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Geneva'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Olivier T. Rutschmann', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}