Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 6:35 AM
Study NCT ID:
NCT04436718
Status:
UNKNOWN
Last Update Posted:
2020-06-18
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-08', 'size': 180924, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-15T04:41', 'hasProtocol': True}, {'date': '2019-06-05', 'size': 169083, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-15T04:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized open label controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-15', 'studyFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worsening renal failure', 'timeFrame': 'During hospitalization typically one week', 'description': 'Serum Creatnine levels measured in mg/dL'}], 'secondaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'During hospitalization typically one week', 'description': 'Measured in days from initial admission to discharge'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Point of care ultrasound', 'Focused cardiac ultrasound', 'heart failure', 'inferior vena cava', 'POCUS', 'CHF', 'FCU', 'acute heart failure', 'decompensated heart failure'], 'conditions': ['Acute Decompensated Heart Failure']}, 'descriptionModule': {'briefSummary': 'This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart failure with primary end point of acute kidney injury while in hospital.', 'detailedDescription': 'Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a significant morbidity and premature mortality. Administration of intravenous (IV) diuretics is largely guided by clinical judgment based on physical exam, net fluid measurement, changes in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis while improving symptoms, without compromising renal function. Laboratory tests demonstrating hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from inadequate predictive value. Observational studies have identified worsening renal failure (WRF) in patients admitted for heart failure as an important clinical entity associated with worsening clinical outcomes.\n\nPoint of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic information obtained and interpreted at bedside that can augment and enhance the physical examination. Numerous studies have examined POCUS assessment of pulmonary edema and measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 admitted for acute decompensated heart failure exacerbation as primary admission diagnosis from Emergency department to General Medicine ward that are administered diuretic therapy expected to be admitted for two days or more.\n\nExclusion Criteria:\n\n1. Decline consent for study\n2. If admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration\n3. Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD)\n4. Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.)\n5. Patients admitted to ICU\n6. Patients currently on positive pressure ventilation (BiPAP)\n7. Patients discharged from the emergency department\n8. Patients discharged prior to evaluation by the POCUS team'}, 'identificationModule': {'nctId': 'NCT04436718', 'briefTitle': 'Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?', 'organization': {'class': 'OTHER', 'fullName': 'Riverside University Health System Medical Center'}, 'officialTitle': 'Does Serial Ultrasonographic Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?', 'orgStudyIdInfo': {'id': '1374867-5'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily POCUS', 'description': 'Patients are assessed by facility experts with daily chest ultrasound and findings of interstitial syndrome and IVC measurement are reported to primary care providers.', 'interventionNames': ['Diagnostic Test: Daily pocus exam']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Patients are assessed daily by primary care providers per usual care.'}], 'interventions': [{'name': 'Daily pocus exam', 'type': 'DIAGNOSTIC_TEST', 'description': 'Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments', 'armGroupLabels': ['Daily POCUS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92555', 'city': 'Moreno Valley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Ulrich', 'role': 'CONTACT', 'email': 'm.ulrich@ruhealth.org', 'phone': '951-486-4640'}], 'facility': 'RUHS Medical center', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}], 'centralContacts': [{'name': 'Michael Ulrich, MD', 'role': 'CONTACT', 'email': 'm.ulrich@ruhealth.org', 'phone': '9514864640'}, {'name': 'Minho Yu, DO', 'role': 'CONTACT', 'email': 'm.yu@ruhealth.org', 'phone': '9514864640'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riverside University Health System Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Medical Program Director', 'investigatorFullName': 'Michael Ulrich MD', 'investigatorAffiliation': 'Riverside University Health System Medical Center'}}}}