Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-29 @ 7:53 AM
Study NCT ID:
NCT06109532
Status:
UNKNOWN
Last Update Posted:
2023-11-02
First Post:
2023-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D003715', 'term': 'Dengue'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006482', 'term': 'Hemorrhagic Fevers, Viral'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 530}, 'targetDuration': '8 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2023-10-25', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Admission to the hospital', 'timeFrame': 'between january 1, 2023 and november 1, 2023', 'description': 'Risk for admission to the hospital'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HYPONATREMIA', 'DENGUE', 'INFLAMMATION'], 'conditions': ['Hyponatremia', 'Dengue', 'Inflammation']}, 'referencesModule': {'references': [{'pmid': '34926496', 'type': 'BACKGROUND', 'citation': 'Ayus JC, Negri AL, Moritz ML, Lee KM, Caputo D, Borda ME, Go AS, Eghi C. Hyponatremia, Inflammation at Admission, and Mortality in Hospitalized COVID-19 Patients: A Prospective Cohort Study. Front Med (Lausanne). 2021 Dec 2;8:748364. doi: 10.3389/fmed.2021.748364. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.', 'detailedDescription': 'Background Dengue infection is becoming more prevalent worldwide and is associated with systemic inflammation. Systemic Inflammation is associated with non-osmotic release of ADH.\n\nMethods: Participants conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and November 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and May 31, 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis confirmed by PCR, non structural protein 1 (NS1) antigen or IgM serology.\n\nPlasma sodium at admission.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06109532', 'acronym': 'HINDIP', 'briefTitle': 'Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Nacional Profesor Alejandro Posadas'}, 'officialTitle': 'Prevalence of Hyponatremia in Dengue Infected Patients: Relationship With Systemic Inflammation.', 'orgStudyIdInfo': {'id': 'HINDIP162023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DENGUE INFECTED PATIENTS. YEAR 2016', 'description': 'We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2016, and december 31, 2016. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.', 'interventionNames': ['Other: hyponatremia']}, {'label': 'DENGUE INFECTED PATIENTS. YEAR 2020', 'description': 'We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2020, and december 31, 2020. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.', 'interventionNames': ['Other: hyponatremia']}, {'label': 'DENGUE INFECTED PATIENTS. YEAR 2023', 'description': 'We conducted a prospective cohort study in patients with newly diagnosed dengue infection at Hospital Posadas in Argentina, between January 1, 2023, and november 1, 2023. Diagnosis was confirmed by IgM serology or PCR. Hyponatremia was defined as serum sodium concentration ≤135 mEq/L.', 'interventionNames': ['Other: hyponatremia']}], 'interventions': [{'name': 'hyponatremia', 'type': 'OTHER', 'description': 'hyponatremia at admission in dengue infected patients', 'armGroupLabels': ['DENGUE INFECTED PATIENTS. YEAR 2016', 'DENGUE INFECTED PATIENTS. YEAR 2020', 'DENGUE INFECTED PATIENTS. YEAR 2023']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1706', 'city': 'Haedo', 'state': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Ladislao P Diaz-Ballve, Lic.', 'role': 'CONTACT', 'email': 'ladislaodiaz@gmail.com', 'phone': '+54(011)67887437'}], 'facility': 'Ladislao Diaz Ballve', 'geoPoint': {'lat': -34.64239, 'lon': -58.59212}}, {'zip': '1684', 'city': 'Buenos Aires', 'status': 'RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'CARLOS EGHI, PHYSICIAN', 'role': 'CONTACT', 'email': 'carlisluyemm@hotmail.com', 'phone': '+541166939309'}], 'facility': 'Hospital Posadas', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}], 'centralContacts': [{'name': 'CARLOS EGHI, MD', 'role': 'CONTACT', 'email': 'carlisluyemm@hotmail.com', 'phone': '+541166939309'}, {'name': 'LADISLAO DIAZ BALLVE, PHD', 'role': 'CONTACT', 'email': 'ladislaodiaz@gmail.com'}], 'overallOfficials': [{'name': 'CARLOS EGHI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HOSPITAL NACIONAL PROF. A. POSADAS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Nacional Profesor Alejandro Posadas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ladislao Diaz Ballve', 'investigatorAffiliation': 'Hospital Nacional Profesor Alejandro Posadas'}}}}