Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT04972318
Status:
TERMINATED
Last Update Posted:
2024-02-05
First Post:
2021-07-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098968', 'term': 'Community-Acquired Pneumonia'}, {'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}], 'ancestors': [{'id': 'D017714', 'term': 'Community-Acquired Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010807', 'term': 'Physical Endurance'}], 'ancestors': [{'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'whyStopped': 'Low recruitment rate with no possibility to achieve pre specified sample size before funding ends.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2021-07-15', 'studyFirstSubmitQcDate': '2021-07-15', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oxygenation parameters (oxygenation index and fraction of arterial pressure of oxygen over inspired oxygen fraction)', 'timeFrame': '3 days', 'description': 'Measurements of oxygenation in the first 3 days after enrollment (ratio between arterial partial pressure of oxygen over inspired fraction of oxygen, and oxygenation index, defined by mean airway pressure multiplied by fraction of inspired oxygen over arterial partial pressure of oxygen.'}, {'measure': 'Driving Pressure during mechanical ventilation', 'timeFrame': '3 days', 'description': 'Driving pressured, measured once daily and defined by airway plateau pressure minus positive end-expiratory pressure'}, {'measure': 'Intensive Care Unit Free Days', 'timeFrame': '28 days', 'description': 'Number of days the patient spend alive and out of the intensive care unit'}, {'measure': 'Ventilatory Rate', 'timeFrame': '3 days', 'description': 'Ventilatory Rate, measured daily, defined as minute ventilation (in liters) multiplied by arterial partial pressure of oxygen, divided by 37.5 multiplied by patient weight (in kilograms) multiplied by 100'}], 'primaryOutcomes': [{'measure': 'Mechanical ventilation free days', 'timeFrame': '28 days', 'description': 'Number of days patient remains independent of mechanical ventilation'}], 'secondaryOutcomes': [{'measure': 'Hospital Mortality', 'timeFrame': '90 days', 'description': 'Whether the patient perished or not during hospitalization'}, {'measure': 'Intensive Care Unit Mortality', 'timeFrame': '90 days', 'description': 'Whether the patient perished or not during intensive care unit stay, truncated at 28 days'}, {'measure': 'Need for rescue therapies for refractory hypoxemia', 'timeFrame': '28 days', 'description': 'Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days'}, {'measure': 'Occurrence of barotrauma', 'timeFrame': '28 days', 'description': 'Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mechanical ventilation', 'positive end-expiratory pressure', 'community-acquired pneumonia'], 'conditions': ['Community-acquired Pneumonia', 'Acute Respiratory Distress Syndrome']}, 'referencesModule': {'references': [{'pmid': '39592365', 'type': 'DERIVED', 'citation': 'Maia IS, Cavalcanti AB, Tramujas L, Veiga VC, Oliveira JS, Sady ERR, Barbante LG, Nicola ML, Gurgel RM, Damiani LP, Negrelli KL, Miranda TA, Laranjeira LN, Tomazzini B, Zandonai C, Pincelli MP, Westphal GA, Fernandes RP, Figueiredo R, Sartori Bustamante CL, Norbin LF, Boschi E, Lessa R, Romano MP, Miura MC, Soares de Alencar Filho M, Ces de Souza Dantas V, Barreto PA, Hernandes ME, Grion C, Laranjeira AS, Mezzaroba AL, Bahl M, Starke AC, Biondi R, Dal-Pizzol F, Caser E, Thompson MM, Padial AA, Leite RT, Araujo G, Guimaraes M, Aquino P, Lacerda F, Hoffmann Filho CR, Melro L, Pacheco E, Ospina-Tascon G, Ferreira JC, Calado Freires FJ, Machado FR, Zampieri FG; BRICNet. Effect of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome secondary to community-acquired pneumonia: the STAMINA randomised clinical trial. Br J Anaesth. 2025 Mar;134(3):693-702. doi: 10.1016/j.bja.2024.10.012. Epub 2024 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.', 'detailedDescription': 'There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking.\n\nWe will perform an open label randomized controlled trial comparing both strategies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with community acquired pneumonia requiring invasive mechanical ventilation\n* Bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician\n* One of the criteria below:\n* Oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmH2O to main peripheral oxygen saturation above 93%, OR\n* Arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with PEEP values of at least 5 cmH2O\n\nExclusion Criteria:\n\n* Patients with inclusion criteria for more than 36 hours\n* Refusal of the patient´s legal representative\n* Acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension)\n* Patients with current airway fistula or barotrauma\n* Patients on chronic home use of oxygen due to underlying lung disease\n* Patients younger than 18 years\n* Patients not on full code status'}, 'identificationModule': {'nctId': 'NCT04972318', 'acronym': 'STAMINA', 'briefTitle': 'Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Prospective, Randomized, Controlled Trial Assessing the Effects of a Driving-pressure Limiting STrAtegy for Patients With Acute Respiratory Distress Syndrome Due to coMmunIty-acquired pNeumoniA (STAMINA Trial)', 'orgStudyIdInfo': {'id': 'stamina_trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ARDSNet strategy', 'description': 'Patients will receive a mechanical ventilation strategy based on fixed values of positive end-expiratory pressure according to inspired fraction of oxygen.\n\nPlateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.\n\nThis arm is similar to the ARMA (Ventilation with Lower Tidal Volumes as Compared with Traditional Tidal Volumes for Acute Lung Injury and the Acute Respiratory Distress Syndrome) trial.', 'interventionNames': ['Procedure: ARDSNet ventilatory strategy']}, {'type': 'EXPERIMENTAL', 'label': 'STAMINA strategy', 'description': 'Patients will receive a mechanical ventilation strategy based on positive end-expiratory pressure tailored to achieve the optimal respiratory system compliance and to have driving pressure limited to 14 cmH2O.\n\nPlateau pressure will be limited at 30 cmH2O. This strategy will be mantained and monitored for 3 days, unless the patient dies or is extubated before.', 'interventionNames': ['Procedure: Positive end-expiratory pressure titration with driving pressure control']}], 'interventions': [{'name': 'Positive end-expiratory pressure titration with driving pressure control', 'type': 'PROCEDURE', 'otherNames': ['STAMINA'], 'description': 'Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.', 'armGroupLabels': ['STAMINA strategy']}, {'name': 'ARDSNet ventilatory strategy', 'type': 'PROCEDURE', 'description': 'Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.', 'armGroupLabels': ['ARDSNet strategy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Londrina', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina', 'geoPoint': {'lat': -23.31028, 'lon': -51.16278}}, {'city': 'Criciúma', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital São José', 'geoPoint': {'lat': -28.6775, 'lon': -49.36972}}, {'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Nereu Ramos', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'Joinville', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Centro Hospitalar Unimed', 'geoPoint': {'lat': -26.30444, 'lon': -48.84556}}, {'zip': '05435000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital do Coracao', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'BP-A Beneficiência Portuguesa de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Israel S Maia, MSc', 'role': 'STUDY_CHAIR', 'affiliation': 'HCor Research Institute'}, {'name': 'Bruno Tomazini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCor Research Institute'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '1 year after publication of primary results', 'ipdSharing': 'YES', 'accessCriteria': 'Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. data privacy law.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brazilian Research In Intensive Care Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}