[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100547790":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":81,"locations":12,"responsibleParty":90,"collaborators":93,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":12,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":12,"enrollmentInfo":106,"targetDuration":12,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":115,"overallStatus":120,"whyStopped":12,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":12},{"fullName":5,"class":6},"Beneficência Portuguesa de São Paulo","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Baseline","NO_INTERVENTION","Participants over 18 years of age admitted to the ICU in the selected hospitals during the study period, using intracranial pressure monitoring catheters and\u002For external ventricular drain. Baseline database obtained from the study \"Device-related Central Nervous System Infections in Adult Intensive Care Units in Brazil (IMPACTO-SNC)\", Carried out during the period from 2022 to 2023.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention","EXPERIMENTAL","Participants over 18 years old admitted to the ICU in the selected hospitals and trained in the intervention bundle during the study period, using intracranial pressure monitoring catheters and\u002For external ventricular shunt. Participants included in the period from 2024 to 2026",[18],"Behavioral: Health care practices and routines",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Health care practices and routines","The scope of the project includes a diagnostic visit to participating hospitals, conducted by the coordinating center team, to understand existing protocols related to the management of invasive central nervous system devices (such as intracranial pressure monitoring catheters or external ventricular drains), as well as the physical infrastructure, human resources, and other precautions taken for the prevention and treatment of central nervous system infections. All recommendations in the intervention bundle for patient care will align with the guidelines of the National Health Surveillance Agency (ANVISA) and the best available scientific evidence for preventing infections associated with central nervous system devices.\n\n* Provide the best care for patients with ICP and\u002For EVD, based on the best available evidence, with regard to the insertion and maintenance of catheters, as well as diagnosis and treatment in the presence of infection.\n* Training of the multidisciplinary team.",[14],[26,30,33,36,39,42,45,48,51,54,57,60,63,66,69,72,75,78],{"name":27,"affiliation":28,"role":29},"Viviane Veiga, Phd","BP - A Beneficência Portuguesa de São Paulo","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Renata Oliveira","Hospital Geral Clériston Andrade",{"name":34,"affiliation":35,"role":29},"Cássia Shinotsuka","Instituto Estadual do Cérebro Paulo Niemeyer",{"name":37,"affiliation":38,"role":29},"Thiago Lisboa","Hospital de Clinicas de Porto Alegre",{"name":40,"affiliation":41,"role":29},"Luciana Sanches","Hospital do Amor de Barretos",{"name":43,"affiliation":44,"role":29},"Lívia Medeiros","Hospital Pelópidas Silveira",{"name":46,"affiliation":47,"role":29},"Tássio Lavor","Hospital Getúlio Vargas",{"name":49,"affiliation":50,"role":29},"Débora Pinho","Hospital da Restauração",{"name":52,"affiliation":53,"role":29},"Cristiano Franke","Hospital de Pronto Socorro de Porto Alegre",{"name":55,"affiliation":56,"role":29},"Gabriela Teixeira","Hospital Universitário Cajuru",{"name":58,"affiliation":59,"role":29},"Eliane Silva","Hospital Universitário Onofre Lopes",{"name":61,"affiliation":62,"role":29},"Marcelo Romano","Hcor - Associação Beneficente Síria",{"name":64,"affiliation":65,"role":29},"Wilson Lovato","Hospital das Clínicas de Ribeirão Preto",{"name":67,"affiliation":68,"role":29},"Israel Maia","Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck",{"name":70,"affiliation":71,"role":29},"Priscila Gonçalves","Santa Casa de Misericordia de Passos",{"name":73,"affiliation":74,"role":29},"Flávia Machado","Hospital São Paulo",{"name":76,"affiliation":77,"role":29},"Glécia Rocha","Instituto Hospital de Base do Distrito Federal - IGESDF",{"name":79,"affiliation":80,"role":29},"Roberta Roepek","Hospital das Clínicas FMUSP",[82,86],{"name":27,"role":83,"phone":84,"phoneExt":12,"email":85},"CONTACT","+55 11 99942-1721","viviane.veiga@bp.org.br",{"name":87,"role":83,"phone":88,"phoneExt":12,"email":89},"Juliana Coelho, Phd","+55 11 98971-5801","juliana.coelho@bp.org.br",{"type":29,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Viviane Cordeiro Veiga, MD, PhD","Principal Investigator",[94],{"name":95,"class":96},"Ministry of Health, Brazil","OTHER_GOV","100547790","effect-of-a-bundle-of-interventions-on-the-outcomes-of-patients-with-intracranial-devices-icp-monitor-e-evd-100547790",false,"NCT06412549","Effect of a Bundle of Interventions on the Outcomes of Patients With Intracranial Devices (ICP Monitor e EVD)","IMPACTO MR: Effect of a Bundle of Interventions on Patients With Central Nervous System Devices - Project Platform Supporting the National Action Plan for Prevention and Control of Antimicrobial Resistance","Inclusion Criteria:\n\n* Adult patients with intracranial pressure monitoring catheters (intraventricular or intraparenchymal) and\u002For external ventricular drain.\n* The patient can be included from the moment the catheter is implanted, without there being a minimum time for inclusion.\n\nExclusion Criteria:\n\n* Suspected or confirmed brain death.","ALL","18 Years",{"count":107,"type":108},1300,"ESTIMATED","INTERVENTIONAL",[111],"NA","Non-randomized clinical trial conducted in the adult ICUs of Brazilian hospitals participating in the IMPACTO MR Platform, involving adult patients using an intracranial pressure monitoring catheter device or external ventricular drain.\n\nThe study will test the hypothesis that the intervention bundle, following ANVISA recommendations for care practices, will reduce the rates of central nervous system infections associated with ICP and EVD devices.\n\nThis reduction is expected to lead to more accurate diagnoses, decreased antibiotic usage, shortened ICU and hospital stays, and reduced hospital costs.",[114],"Central Nervous System Infections",[116,117,118,119],"Bacterial resistance","Health care","Central nervous systen infection","Multi-resistant microorganism","NOT_YET_RECRUITING","2024-05-08",{"date":123,"type":124},"2024-05-14","ACTUAL",{"date":126,"type":108},"2024-06-01",{"date":128,"type":108},"2026-12-31",{"name":5,"class":6}]