Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT03405051
Status:
COMPLETED
Last Update Posted:
2019-02-04
First Post:
2018-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D007008', 'term': 'Hypokalemia'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2018-01-12', 'studyFirstSubmitQcDate': '2018-01-12', 'lastUpdatePostDateStruct': {'date': '2019-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of death and re-hospitalization', 'timeFrame': 'Month 3', 'description': 'The number of death for any reason and re-hospitalization for congestive heart failure'}], 'secondaryOutcomes': [{'measure': 'Death', 'timeFrame': 'Month 3', 'description': 'Percentage of death for any reason'}, {'measure': 'Re-hospitalization', 'timeFrame': 'Month 3', 'description': 'Percentage of re-hospitalization for congestive heart failure'}, {'measure': 'Length of stay', 'timeFrame': 'Month 3', 'description': 'Days spent at the hospital'}, {'measure': 'Incidence of hypokalemia', 'timeFrame': 'Month 3', 'description': 'Percentage of incidence during the stay of hypokalemia'}, {'measure': 'Prevalence of hypokalemia', 'timeFrame': 'Month 3', 'description': 'Percentage of initial prevalence during the stay of hypokalemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypokalemia', 'cardiac failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Hypokalemia is very common in heart failure patients. Deleterious effects have been report on the cardiovascular system. Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.', 'detailedDescription': 'This study tried to describe hypokalemia impact during hospital stay in hospitalized patients with heart failure and particularly on mortality and re-hospitalization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with congestive heart failure admitted to the Heart Failure Unit in the Mercy hospital (CHR Metz-Thionville).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville\n* Patient with congestive heart failure\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT03405051', 'acronym': 'HYPIC', 'briefTitle': 'Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact', 'orgStudyIdInfo': {'id': '2017-03Obs-CHRMT'}}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}