Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT07085793
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2025-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Estimated Plasma Volume in Patients With Acute Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}, 'targetDuration': '365 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-01', 'studyFirstSubmitDate': '2025-07-17', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'readmission for AHF and/or all-cause mortality', 'timeFrame': '30 days', 'description': 'readmission for AHF and/or all-cause mortality at 1 month'}, {'measure': 'readmission for AHF and/or all-cause mortality', 'timeFrame': '365 days', 'description': 'readmission for AHF and/or all-cause mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Estimated plasma volume status (ePVS)'], 'conditions': ['Acute Heart Failure']}, 'descriptionModule': {'briefSummary': 'Congestion plays an essential role in acute heart failure (AHF) outcomes. Estimated plasma volume status (ePVS), derived from simple hematological parameters, may offer prognostic value.\n\nThe objectif is to assess the prognostic value of admission ePVS, calculated using Duarte and Hakim formulas, for short- and long-term mortality and/or readmission in patients hospitalized for AHF.', 'detailedDescription': 'it is a prospective cross-sectional study in the emergency department of Fattouma Bourguiba University Hospital of Monastir, Tunisia.This study was approved by the Institutional Review Boardof our institute and conducted according to the revised Declaration of Helsinki. The requirement of written informed consent was waived, as this study is observational. an opt-out method was used for participant recruitment.\n\nePVS at admission was calculated as follows:\n\n* Duarte ePVS= 100-ht(%) /Hb(g/dl).\n* Hakim ePVS = \\[(actual plasma volume-ideal plasma volume)/ideal plasma volume\\] × 100 Actual plasma volume: (1-hematocrit) × (a+b×body weight in kg). Ideal plasma volume = c×body weight in kg. (males: a = 1530, b = 41.0, c = 39; females; a = 864, b = 47.9, c = 40)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with acute heart failure admetted in emergency department', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusiuon criteria :\n* Patients aged over 18\n* diagnosis of AHF based on clinical examination, echocardiography, the value of BNP or NT pro-BNP and expert opinion.\n* Exclusion criteria :\n* pregnancy\n* end-stage or severe renal failure with creatinine clearance \\< 15 ml/min\n* hemodialysis.\n* refusal to consent\n* Pregnant or breast feeding women.\n* Alteration of consciousness GCS \\< 15\n* Critically ill patients needing immediate mechanical hemodynamic of ventilatory support.\n* Inability to follow instructions or comply with follow-up procedures.'}, 'identificationModule': {'nctId': 'NCT07085793', 'acronym': 'ePVS', 'briefTitle': 'Estimated Plasma Volume in Patients With Acute Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Prognostic Value of Estimated Plasma Volume in Patients With Acute Heart Failure', 'orgStudyIdInfo': {'id': 'Estimated plasma volume- ePVS'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': '1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency Department', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'Semir Nouira, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}