Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-29 @ 8:29 AM
Study NCT ID:
NCT03658850
Status:
UNKNOWN
Last Update Posted:
2019-04-30
First Post:
2018-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006955', 'term': 'Hypernatremia'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006852', 'term': 'Hydrochlorothiazide'}], 'ancestors': [{'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-03-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-09-03', 'lastUpdatePostDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hypernatremia correction', 'timeFrame': 'DAY 3', 'description': 'proportion of patients with hypernatremia correction (serum sodium below 145 mEq / L) at the end of Day 3'}], 'secondaryOutcomes': [{'measure': 'renal replacement therapy', 'timeFrame': '6 months', 'description': 'need to renal replacement therapy'}, {'measure': 'mechanical ventilation', 'timeFrame': '6 months', 'description': 'incidence of mechanical ventilation'}, {'measure': 'vasoactive drugs', 'timeFrame': '6 months', 'description': 'need for vasoactive drugs'}, {'measure': 'mortality', 'timeFrame': '6 months', 'description': 'hospital mortality'}, {'measure': 'serious adverse events', 'timeFrame': '6 months', 'description': 'incidence of serious adverse events 37/5000 incidence of serious adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypernatremia', 'Critical care'], 'conditions': ['Hypernatremia', 'Critical Illness']}, 'descriptionModule': {'briefSummary': 'HYDRA is a randomized clinical trial designed to evaluate safety and efficiency of hydrochlorothiazide in critical patients with hypernatremia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hospitalized for intensive care,\n* Over 18 years of age,\n* Two serum sodium measurements above 145 mEq / L (with no pre-determined interval between them),\n* Mean arterial pressure greater than 65mmHg\n\nExclusion Criteria:\n\n* Absence of consent to participate in the study\n* Cardiac index below 2.5L / min / m2 OR signs of ineffective circulation (capillary filling time greater than 2 seconds, cold or sticky skin) OR arterial lactate\\> 4mMol / L.\n* Use of vasopressors at doses greater than 0.1 mcg / kg / min of noradrenaline or with initiation or increase of dose within less than one hour before inclusion in the study.\n* Unavailable enteral route.\n* Use of hydrochlorothiazide in the last 7 days of ICU admission.\n* History of allergy or intolerance to hydrochlorothiazide or other thiazides.\n* Nephrogenic Diabetes Insipidus.\n* Renal impairment KDIGO 3\n* Indication of renal replacement therapy.\n* Acute neurological insult.\n* Heart failure American Heart Association classification (AHA), class D.\n* Liver cirrhosis Child-Pugh C.\n* Pregnant women\n* Exclusive palliative care\n* Dying, with expected survival less than 48 hours'}, 'identificationModule': {'nctId': 'NCT03658850', 'acronym': 'HYDRA', 'briefTitle': 'Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Safety and Efficacy of Hydrochlorothiazide in the Treatment of Hypernatremia in Critically Ill Patients: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2.603.927'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'the experimental group will receive one tablet of hydrochlorothiazide in the presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally for 3 days.', 'interventionNames': ['Drug: Hydrochlorothiazide 50Mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'placebo group will receive one tablet or equivalent volume of enteral solution of inert substance', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Hydrochlorothiazide 50Mg', 'type': 'DRUG', 'description': 'for the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3', 'armGroupLabels': ['Intervention']}, {'name': 'Placebos', 'type': 'DRUG', 'description': 'for the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'André LN Gobatto, M.D.', 'role': 'CONTACT', 'email': 'andregobatto@gmail.com', 'phone': '+5511991796501'}, {'name': 'André LN Gobatto, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'André LN Gobatto, p.h.d', 'role': 'CONTACT', 'email': 'andregobatto@gmail.com', 'phone': '+5571988646501'}], 'overallOfficials': [{'name': 'André LN Gobatto, p.h.d', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'André Luiz Nunes Gobatto', 'investigatorAffiliation': 'University of Sao Paulo'}}}}