Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT04253405
Status:
TERMINATED
Last Update Posted:
2021-08-16
First Post:
2020-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D063087', 'term': 'Noninvasive Ventilation'}], 'ancestors': [{'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study impacted by the COVID-19 pandemic:\n\n* slow recruitment rate\n* budget constrains', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-09', 'studyFirstSubmitDate': '2020-01-31', 'studyFirstSubmitQcDate': '2020-02-03', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comfort visual analog scale variation', 'timeFrame': '7 days', 'description': 'Confort scale'}, {'measure': 'Endotracheal intubation (ETI) rate', 'timeFrame': '7 days', 'description': 'Endotracheal intubation'}, {'measure': 'Mortality', 'timeFrame': '28 days', 'description': 'Mortality in 28 days'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'Mortality in 90 days'}], 'primaryOutcomes': [{'measure': 'Recruitment feasibility', 'timeFrame': '18 months', 'description': 'Recruitment of 50 pulmonary fibrosis patients in acute respiratory failure in 18 months'}], 'secondaryOutcomes': [{'measure': 'Dyspneia variation (Borg scale)', 'timeFrame': '7 days', 'description': 'Borg scale'}, {'measure': 'Respiratory frequency variation', 'timeFrame': '7 days', 'description': 'Respiratory rate'}, {'measure': 'oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) variation', 'timeFrame': '7 days', 'description': 'Oxygen index'}, {'measure': 'Carbon dioxide arterial partial pressure (PaCO2) variation', 'timeFrame': '7 days', 'description': 'CO2 variation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Respiratory Failure', 'Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'A pilot multicentric randomized controlled study investigating the feasibility of recruiting 50 pulmonary fibrosis patients in acute respiratory failure within18 months. Additionally, exploratory efficacy and safety outcomes will be evaluated.', 'detailedDescription': 'RENOVATE Fibrosis will recruit patients with pulmonary fibrosis in acute respiratory failure to be randomized to HFNC or NIPPV. Efficacy and safety outcomes measured are dyspnea variation, physiological variables (pCO2, respiratory rate, oxygenation), comfort, endotraqueal intubation rate, mortality in 28 and 90 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Sequential adult patients 18 years of age or older admitted to the hospital with pulmonary fibrosis and acute onset of respiratory failure that meets criteria A and B bellow.\n\nA. Pulmonary fibrosis will be defined by all of the criteria below:\n\n* presence of Velcro-type crackles on physical examination\n* imaging compatible with pulmonary fibrosis\n* diffuse disease on imaging\n\nB. Acute respiratory failure (ARF) will be defined by hypoxemia evidenced by SpO2 \\<90% or PaO2 \\<60 mmHg in room air and at least two of the criteria below within the last four weeks:\n\n* worsening dyspnea\n* worsening breathing effort\n* worsening gas exchange (worsening SpO2 or paO2)\n* worsening respiratory rate, above 25 irpm\n\nExclusion Criteria:\n\n* Pulmonary fibrosis secondary to progressive massive fibrosis (silicosis), or any other tumor form of fibrosis;\n* Significant pulmonary arterial hypertension characterized by: Right ventricular failure on Doppler echocardiogram or Cardiac index \\<2L / min / m2 in catheterization of right chambers;\n* Pneumothorax or extensive pleural effusion as the main determinant of ARF in the assessment of the attending physician;\n* Cardiogenic pulmonary congestion as the main determinant of IRPA in the assessment of the attending physician;\n* Presence of delirium or non-cooperation at the time of randomization;\n* Anatomical facial abnormalities;\n* Incoercible vomiting or hypersecretion of the airways;\n* Use of continuous VNIPP or HFNC for more than 8h before randomization;\n* pregnancy;\n* Refusal to participate.'}, 'identificationModule': {'nctId': 'NCT04253405', 'acronym': 'Fibrosis', 'briefTitle': 'RENOVATE Fibrosis:HFNC Versus NIPPV in Acute Respiratory Failure in Patients With Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Multicentric Randomized Controlled Pilot Study Comparing High Flow Nasal Cannula Versus NonInvasive Positive Pressure Ventilation in Acute Respiratory Failure in Patients With Pulmonary Fibrosis (RENOVATE Fibrosis)', 'orgStudyIdInfo': {'id': 'IP-HCOR/RENOVATEfibrose'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High Flow Nasal Cannula (HFNC)', 'description': 'The HFNC (Airvo2 Fisher \\& Paykel, Auckland, New Zealand) consists of an apparatus that allows adjustable FiO2 from 21 to 100% and delivers flow up to 60 L/ min.', 'interventionNames': ['Device: High Flow Nasal Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-invasive positive pressure ventilation (NIPPV)', 'description': 'NIPPV will be performed using the devices available on centers. Both a dedicated NIPPV device or an invasive mechanical ventilator with NIPPV mode are accepted. The interface should be an oronasal or full face mask.', 'interventionNames': ['Device: Noninvasive positive pressure ventilation (NIPPV)']}], 'interventions': [{'name': 'High Flow Nasal Catheter', 'type': 'DEVICE', 'otherNames': ['Optiflow', 'Airvo', 'trans-nasal insufflation', 'Nasal High Flow', 'High Flow Nasal Cannula'], 'description': 'HFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees.\n\nOxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2', 'armGroupLabels': ['High Flow Nasal Cannula (HFNC)']}, {'name': 'Noninvasive positive pressure ventilation (NIPPV)', 'type': 'DEVICE', 'otherNames': ['BiPAP', 'Non-invasive ventilation', 'Non-invasive positive pressure ventilation'], 'description': 'NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.', 'armGroupLabels': ['Non-invasive positive pressure ventilation (NIPPV)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vitória', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Hospital UNIMED Vitória', 'geoPoint': {'lat': -20.31944, 'lon': -40.33778}}, {'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital de Brasilia (HOBRA)', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Nereu Ramos', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia Dante Pazanese', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coracao', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'InCor - Hospital das Clinicas da Faculdade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Leticia Kawano-Dourado, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coração'}, {'name': 'Israel Maia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital do Coração'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'In 8 months', 'ipdSharing': 'YES', 'description': 'Data sharing plan - under construction', 'accessCriteria': 'Publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}, {'name': 'Fisher and Paykel Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}