Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-04 @ 2:14 PM
Study NCT ID:
NCT05415904
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2022-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018778', 'term': 'Hantavirus Infections'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D002044', 'term': 'Bunyaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2022-05-22', 'studyFirstSubmitQcDate': '2022-06-08', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinin level', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Acute Kidney injury KDIGO 3'}, {'measure': 'Hemorrhagic syndrome', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Major bleeding requiring blood transfusion'}, {'measure': 'Death', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Death'}, {'measure': 'Hospitalisation in intensive care unit', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Hospitalisation in intensive care unit'}], 'secondaryOutcomes': [{'measure': 'Score performance to predict severity', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Correlation between severity predicted by the score and bio-clinical severity during hospitalization.\n\nScore composition :\n\nHematuria = 7 Visual disorders = 8 Leucocyte count \\> 10 x 10\\^9 cells/L = 9 Nephrotoxic drug exposure (NSAID, iodinated contrast media, diuretics, renin angiotensin aldosterone system inhibitors, aminoglycosides, glycopeptides) = 10 Thrombocytopenia \\< or = 90 000/mm3 = 11\n\nRisk group according score scale 0-10 Low risk 11-19 intermediate risk 20-45 high risk'}, {'measure': 'Hypotension', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Lowest systolic blood presure during hospitalisation \\< 90mmHg'}, {'measure': 'Proteinuria', 'timeFrame': 'Through study completion,an average of 2 years', 'description': 'Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent'}, {'measure': 'Urinary dipstick', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Leucocyturia or hematuria'}, {'measure': 'ALAT, ASAT', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Liver cytolysis'}, {'measure': 'calcium', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'hypocalcemia, hypercalcemia'}, {'measure': 'phosphorus', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'hypophaspahtaemia, hyperphasphatemia'}, {'measure': 'potassium', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'hypokaliemia, hyperkaliemia'}, {'measure': 'sodium', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'blood sodium level disorders'}, {'measure': 'bicarbonate blood level', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'metabolic acidosis, metabolic alcalosis'}, {'measure': 'Heamoglobin', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Anemia'}, {'measure': 'platelets level', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'thrombocytemia'}, {'measure': 'Urine output', 'timeFrame': 'Through study completion, an average of 2 years', 'description': 'Polyruria above 3 L/day'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute kidney injury', 'Hantavirus infection', 'Hantavirus nephropathy'], 'conditions': ['Hantavirus Nephropathy', 'Hantavirus Infection']}, 'descriptionModule': {'briefSummary': "Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).\n\nThis retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '125 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults patient hospitalized for hantavirus infection during study time frame.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hantavirus proven by serology infection\n* age above 18 years\n* Hospitalisation\n\nExclusion Criteria:\n\n* age under 18 years\n* fulfill opposition form'}, 'identificationModule': {'nctId': 'NCT05415904', 'acronym': 'HANTA-NE', 'briefTitle': 'Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools', 'orgStudyIdInfo': {'id': '2022PI034'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HANTA-NE', 'description': 'All adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France', 'interventionNames': ['Other: HANTA-NE']}], 'interventions': [{'name': 'HANTA-NE', 'type': 'OTHER', 'description': 'Observational cohort study', 'armGroupLabels': ['HANTA-NE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'country': 'France', 'facility': 'Central Hospital', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Alice CORBEL, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central Hospital, Nancy, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'CORBEL Alice', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}