Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol

dc.article.numberCD011703
dc.contributor.authorKattan E.
dc.contributor.authorCastro R.
dc.contributor.authorHernandez G.
dc.contributor.authorBakker J.
dc.contributor.authorEstenssoro E.
dc.contributor.authorOspina-Tascon G.A.
dc.contributor.authorCavalcanti A.B.
dc.contributor.authorDe Backer D.
dc.contributor.authorVieillard-Baron A.
dc.contributor.authorTeboul J.-L.
dc.date.accessioned2025-05-01T10:30:48Z
dc.date.available2025-05-01T10:30:48Z
dc.date.issued2022
dc.description.abstract© 2022 Associacao de Medicina Intensiva Brasileira - AMIB. All rights reserved.Background: Early reversion of sepsis-induced tissue hypoperfusion is essential for survival in septic shock. However, consensus regarding the best initial resuscitation strategy is lacking given that interventions designed for the entire population with septic shock might produce unnecessary fluid administration. This article reports the rationale, study design and analysis plan of the ANDROMEDA-2 study, which aims to determine whether a peripheral perfusion-guided strategy consisting of capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes is associated with a decrease in a composite outcome of mortality, time to organ support cessation, and hospital length of stay compared to standard care in patients with early (< 4 hours of diagnosis) septic shock. Methods: The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial. In the intervention group, capillary refill time will be measured hourly for 6 hours. If abnormal, patients will enter an algorithm starting with pulse pressure assessment. Patients with pulse pressure less than 40mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with pulse pressure > 40mmHg, norepinephrine will be titrated to maintain diastolic arterial pressure > 50mmHg. Patients who fail to normalize capillary refill time after the previous steps will be subjected to critical care echocardiography for cardiac dysfunction evaluation and subsequent management. Finally, vasopressor and inodilator tests will be performed to further optimize perfusion. A sample size of 1,500 patients will provide 88% power to demonstrate superiority of the capillary refill time-targeted strategy. Conclusions: If hemodynamic phenotype-based, capillary refill time-targeted resuscitation demonstrates to be a superior strategy, care processes in septic shock resuscitation can be optimized with bedside tools.
dc.description.funderCentre of Excellence in Population Ageing Research
dc.description.funderColumbia University School of Nursing Center for Health Policy
dc.description.funderFostering Talents of Basic Science
dc.description.funderNIH Roadmap for Medical Research
dc.description.funderNational Institute of MentalHealth
dc.description.funderNationalHeart, Lung, and Blood Institute
dc.description.funderNatural Experiments for Translation in Diabetes
dc.description.funderPittsburgh Health Institute
dc.description.funderRobert Wood Johnson
dc.description.funderRobert Wood Johnson Physician
dc.description.funderSigma Theta Tau International Honor Society of Nursing Alpha Zeta Chapter
dc.description.funderUCLA Resource Center for Minority Aging Research
dc.description.funderUniversity of Chicago Program for Pharmaceutical Policy Research
dc.description.funderVeterans Administration Health Services Research and Development Service
dc.description.funderWilliam F. Milton Fund
dc.description.funderNational Institutes of Health
dc.description.funderNational Institute of Mental Health
dc.description.funderCenters for Disease Control and Prevention
dc.description.funderAmerican Cancer Society
dc.description.funderNational Institute on Aging
dc.description.funderNational Heart, Lung, and Blood Institute
dc.description.funderNational Cancer Institute
dc.description.funderNational Institutes of Health National Institute of General Medical Sciences
dc.description.funderNIDDK
dc.description.funderNational Center for Research Resources
dc.description.funderAgency for Healthcare Research and Quality
dc.description.funderDoris Duke Charitable Foundation
dc.description.funderRobert Wood Johnson Foundation
dc.description.funderAlfred P. Sloan Foundation
dc.description.funderJohn A. Hartford Foundation
dc.description.funderMerck Foundation
dc.description.funderPharmaceutical Research and Manufacturers of America
dc.description.funderPfizer Inc
dc.description.funderMerck & Co
dc.description.funderCecil G. Sheps Center for Health Services Research
dc.description.funderUniversity of Wisconsin Institute for Clinical and Translational Research
dc.description.funderHarvard Medical School
dc.description.funderUNC
dc.description.funderNorwegian Agency for Development Cooperation
dc.description.funderUniversity of North Carolina at Chapel Hill
dc.description.funderUniversity of Arizona
dc.description.funderUniversity of Pittsburgh
dc.description.funderAgency for Health Care Research and Quality
dc.description.funderCanadian Institutes of Health Research
dc.description.funderOntario HIV Treatment Network
dc.description.funderMichael Smith Foundation for Health Research
dc.description.funderAustralian Research Council
dc.description.funderChinese National Natural Science Foundation
dc.description.funderMinistry of Education of the Republic of Korea
dc.description.funderNational Research Foundation of Korea
dc.description.funderChina Scholarship Council
dc.description.funderUPMC
dc.description.funderGeneva University Hospitals
dc.format.extent133 páginas
dc.fuente.origenScopus
dc.identifier.doi10.5935/0103-507X.20220004
dc.identifier.eissn19824335
dc.identifier.issn0103507X
dc.identifier.pubmedid35766659
dc.identifier.scieloidS0718-69242020000300109
dc.identifier.scopusidSCOPUS_ID:85131238519
dc.identifier.urihttps://doi.org/10.5935/0103-507X.20220004
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/103667
dc.identifier.wosidWOS:000804126100018
dc.information.autorucEscuela de Medicina; Castro Lopez Ricardo Adolfo; 0000-0002-0978-9891; 4537
dc.information.autorucEscuela de Medicina; Kattan Tala Eduardo Jose; 0000-0002-1997-6893; 172152
dc.information.autorucEscuela de Medicina; Hernandez Poblete Glenn Wilson; 0000-0002-3032-4087; 98874
dc.issue.numero1
dc.language.isoen
dc.nota.accesoSin adjunto
dc.pagina.final133
dc.pagina.inicio97
dc.relation.ispartofRevista Brasileira de Terapia Intensiva
dc.revistaRevista Brasileira de Terapia Intensiva
dc.rightsAcceso abierto
dc.subjectAlgorithm
dc.subjectCapillary refill time
dc.subjectCritical care
dc.subjectEchocardiography
dc.subjectLength of stay
dc.subjectNorepinephrine
dc.subjectPerfusion
dc.subjectPhenotype
dc.subjectSepsis
dc.subjectSeptic shock
dc.subject.ddc620
dc.subject.deweyIngenieríaes_ES
dc.subject.ods11 Sustainable cities and communities
dc.subject.odspa11 Ciudades y comunidades sostenibles
dc.titleHemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol
dc.typeartículo
dc.volumen34
sipa.codpersvinculados4537
sipa.codpersvinculados172152
sipa.codpersvinculados98874
sipa.indexScopus
sipa.trazabilidadCarga WOS-SCOPUS;01-05-2025
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