Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-02-22 @ 7:02 AM
Study NCT ID:
NCT03557957
Status:
COMPLETED
Last Update Posted:
2025-07-11
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcome assessors will be blinded to allocated treatment group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, controlled, parallel-group trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2278}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-06-04', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is the combined risk of death or rehospitalization within 30 days', 'timeFrame': '30 days', 'description': 'Rate of death or rehospitalization within 30 days'}], 'secondaryOutcomes': [{'measure': '30 days mortality rate', 'timeFrame': '30 days', 'description': 'Mortality rate'}, {'measure': '1 year mortality rate', 'timeFrame': '1 year', 'description': 'Mortality rate'}, {'measure': '30 days rehospitalization rate', 'timeFrame': '30 days', 'description': 'Rehospitalization rate'}, {'measure': '1 year rehospitalization rate', 'timeFrame': '1 year', 'description': 'Rehospitalization rate'}, {'measure': 'Time to rehospitalization', 'timeFrame': 'up to 1 year', 'description': 'Days until first rehospitalization'}, {'measure': 'Time to death', 'timeFrame': 'up to 1 year', 'description': 'Days until death'}, {'measure': 'length of hospital stay', 'timeFrame': 'up to 1 year', 'description': 'length of index hospital stay in days'}, {'measure': 'Rate of falls', 'timeFrame': '30 days', 'description': 'Number of falls'}, {'measure': 'Rate of fractures', 'timeFrame': '30 days', 'description': 'Number of bone fractures'}, {'measure': 'Rate of fractures', 'timeFrame': '1 year', 'description': 'Number of bone fractures'}, {'measure': 'Rate of Plasma sodium normalization at discharge', 'timeFrame': 'up to 1 year', 'description': 'Rate of Plasma sodium Levels \\>=135mmol/L at discharge'}, {'measure': 'Change in Plasma sodium Levels', 'timeFrame': 'up to 1 year', 'description': 'Change in mmol/L in Plasma sodium Levels from inclusion to discharge'}, {'measure': 'Recurrence of hyponatremia', 'timeFrame': '30 days', 'description': 'Rate of recurrence of hyponatremia'}, {'measure': 'Recurrence of hyponatremia', 'timeFrame': '1 year', 'description': 'Rate of recurrence of hyponatremia'}, {'measure': 'Severely symptomatic hyponatremia', 'timeFrame': 'up to 1 year', 'description': 'Rate of severely symptomatic hyponatremia requiring intensive care Treatment during index hospitalization'}, {'measure': 'Sodium-overcorrection', 'timeFrame': 'up to 1 year', 'description': 'Rate of plasma sodium overcorrection during index hospitalization'}, {'measure': 'number of adverse events', 'timeFrame': '30 days', 'description': 'Rate of adverse events'}, {'measure': 'number of adverse events', 'timeFrame': '1 year', 'description': 'Rate of adverse events'}, {'measure': 'Severe adverse events', 'timeFrame': '30 days', 'description': 'Rate of severe adverse events'}, {'measure': 'Severe adverse events', 'timeFrame': '1 year', 'description': 'Rate of severe adverse events'}, {'measure': 'Diagnostic accuracy of copeptin in the diagnosis of hyponatremia', 'timeFrame': '1 day', 'description': 'Copeptin Level will be correlated with final hyponatremia diagnosis'}, {'measure': 'Diagnostic accuracy of mid-regional mid-regional (MR)-proANP in the diagnosis of hyponatremia', 'timeFrame': '1 day', 'description': 'MR-proANP Level will be correlated with final hyponatremia diagnosis N-terminal (NT)-proBNP, aldosterone, renin)'}, {'measure': 'Diagnostic accuracy of NT-proBNP in the diagnosis of hyponatremia', 'timeFrame': '1 day', 'description': 'NT-proBNP Level will be correlated with final hyponatremia diagnosis'}, {'measure': 'Diagnostic accuracy of aldosterone in the diagnosis of hyponatremia', 'timeFrame': '1 day', 'description': 'Aldosterone Level will be correlated with final hyponatremia diagnosis'}, {'measure': 'Diagnostic accuracy of renin in the diagnosis of hyponatremia', 'timeFrame': '1 day', 'description': 'Renin Level will be correlated with final hyponatremia diagnosis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyponatremia']}, 'referencesModule': {'references': [{'pmid': '34552947', 'type': 'DERIVED', 'citation': 'Refardt J, Pelouto A, Potasso L, Hoorn EJ, Christ-Crain M. Hyponatremia Intervention Trial (HIT): Study Protocol of a Randomized, Controlled, Parallel-Group Trial With Blinded Outcome Assessment. Front Med (Lausanne). 2021 Sep 6;8:729545. doi: 10.3389/fmed.2021.729545. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Hyponatremia is the most common electrolyte disorder with a prevalence of up to 30% in hospitalized patients. While treatment of acute hyponatremia with severe clinical symptoms due to cerebral edema is undisputed and straightforward, hyponatremia in general is usually considered asymptomatic or not clinically relevant. Accordingly, a recent observational study showed that appropriate laboratory tests to evaluate the etiology of hyponatremia were obtained in less than 50% of patients, leading to 75% of patients being still hyponatremic at discharge.\n\nThis is problematic in the context of increasing evidence, revealing an association of chronic hyponatremia with adverse effects such as gait alterations and falls, attention deficits, bone loss and fractures as well as disease-associated morbidity leading to increased rates of readmissions and mortality. Yet, there is a complete lack of randomized clinical trials with the primary aim to investigate whether correction of plasma sodium concentration counteracts the elevated risk of rehospitalization and mortality.\n\nThe aim of this trial is therefore to determine the effects on mortality and rehospitalization rate of a targeted correction of plasma sodium concentration in addition to current standard care in hospitalized hyponatremic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult hospitalised patients with hypotonic hyponatremia \\<130mmol/L\n* Hospitalization of at least 24 h after inclusion in the study\n\nExclusion Criteria:\n\n* severe symptomatic hyponatremia in need of intensive care treatment\n* non-hypotonic hyponatremia with plasma osmolality \\>280 milliosmol (mOsm)/kg\n* end of life care (palliative treatment)'}, 'identificationModule': {'nctId': 'NCT03557957', 'acronym': 'HIT', 'briefTitle': 'Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Targeted Correction of Plasma Sodium Levels in Hospitalized Patients With Hyponatremia: a Randomized, Controlled, Parallel-group Trial', 'orgStudyIdInfo': {'id': 'HIT-trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard care plus targeted correction of hyponatremia', 'description': 'Diagnosis and treatment of hyponatremia will be standardized according to the European Clinical Practice Guidelines (ECPG). Treatment response and adherence will be evaluated daily and treatment adapted if treatment goals are not reached.Targeted correction of plasma sodium Levels.', 'interventionNames': ['Other: Targeted correction of plasma sodium levels']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Diagnosis and treatment of hyponatremia will be solely at the discretion of the attending physicians who are in no way involved in the trial. The study team will not intervene with the treatment in any way. Diagnostic and treatment decisions as well as course of the plasma sodium level will only be recorded after patient is discharged from hospital using the medical records and patient charts. It will be generally recommended to measure plasma sodium levels 3x weekly or more frequently if clinically indicated, at discharge and after 30 days.', 'interventionNames': ['Other: Standard care']}], 'interventions': [{'name': 'Targeted correction of plasma sodium levels', 'type': 'OTHER', 'description': 'Targeted correction of hyponatremia', 'armGroupLabels': ['Standard care plus targeted correction of hyponatremia']}, {'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard care of hyponatremia', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'University Hospital Centre Zagreb', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Uniklinik Köln', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Careggi University Hospital Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center Rotterdam', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '4031', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University Hospital Basel, Department of Endocrinology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonsspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4410', 'city': 'Liestal', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}, {'zip': '9000', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantosspital St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '4500', 'city': 'Solothurn', 'country': 'Switzerland', 'facility': 'Solothurner Spitäler AG', 'geoPoint': {'lat': 47.20791, 'lon': 7.53714}}], 'overallOfficials': [{'name': 'Mirjam Christ-Crain, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'url': 'http://dataverse.harvard.edu', 'infoTypes': ['STUDY_PROTOCOL', 'ICF', 'CSR'], 'ipdSharing': 'YES', 'description': 'Metadata describing the type, size and content of the datasets will be shared along with the study protocol and case report forms on the public repository dataverse.harvard.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Erasmus Medical Center', 'class': 'OTHER'}, {'name': 'Cantonal Hospital of Aarau, Switzerland', 'class': 'OTHER'}, {'name': 'Spital Solothurn, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Kantonsspital St. Gallen, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Kantonsspital Liestal, Switzerland', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum Köln', 'class': 'OTHER'}, {'name': 'KBC Zagreb, Croatia', 'class': 'UNKNOWN'}, {'name': 'Azienda Ospedaliero-Universitaria Careggi', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}