Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol
dc.article.number | CD011703 | |
dc.contributor.author | Kattan E. | |
dc.contributor.author | Castro R. | |
dc.contributor.author | Hernandez G. | |
dc.contributor.author | Bakker J. | |
dc.contributor.author | Estenssoro E. | |
dc.contributor.author | Ospina-Tascon G.A. | |
dc.contributor.author | Cavalcanti A.B. | |
dc.contributor.author | De Backer D. | |
dc.contributor.author | Vieillard-Baron A. | |
dc.contributor.author | Teboul J.-L. | |
dc.date.accessioned | 2025-05-01T10:30:48Z | |
dc.date.available | 2025-05-01T10:30:48Z | |
dc.date.issued | 2022 | |
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.funder | Centre of Excellence in Population Ageing Research | |
dc.description.funder | Columbia University School of Nursing Center for Health Policy | |
dc.description.funder | Fostering Talents of Basic Science | |
dc.description.funder | NIH Roadmap for Medical Research | |
dc.description.funder | National Institute of MentalHealth | |
dc.description.funder | NationalHeart, Lung, and Blood Institute | |
dc.description.funder | Natural Experiments for Translation in Diabetes | |
dc.description.funder | Pittsburgh Health Institute | |
dc.description.funder | Robert Wood Johnson | |
dc.description.funder | Robert Wood Johnson Physician | |
dc.description.funder | Sigma Theta Tau International Honor Society of Nursing Alpha Zeta Chapter | |
dc.description.funder | UCLA Resource Center for Minority Aging Research | |
dc.description.funder | University of Chicago Program for Pharmaceutical Policy Research | |
dc.description.funder | Veterans Administration Health Services Research and Development Service | |
dc.description.funder | William F. Milton Fund | |
dc.description.funder | National Institutes of Health | |
dc.description.funder | National Institute of Mental Health | |
dc.description.funder | Centers for Disease Control and Prevention | |
dc.description.funder | American Cancer Society | |
dc.description.funder | National Institute on Aging | |
dc.description.funder | National Heart, Lung, and Blood Institute | |
dc.description.funder | National Cancer Institute | |
dc.description.funder | National Institutes of Health National Institute of General Medical Sciences | |
dc.description.funder | NIDDK | |
dc.description.funder | National Center for Research Resources | |
dc.description.funder | Agency for Healthcare Research and Quality | |
dc.description.funder | Doris Duke Charitable Foundation | |
dc.description.funder | Robert Wood Johnson Foundation | |
dc.description.funder | Alfred P. Sloan Foundation | |
dc.description.funder | John A. Hartford Foundation | |
dc.description.funder | Merck Foundation | |
dc.description.funder | Pharmaceutical Research and Manufacturers of America | |
dc.description.funder | Pfizer Inc | |
dc.description.funder | Merck & Co | |
dc.description.funder | Cecil G. Sheps Center for Health Services Research | |
dc.description.funder | University of Wisconsin Institute for Clinical and Translational Research | |
dc.description.funder | Harvard Medical School | |
dc.description.funder | UNC | |
dc.description.funder | Norwegian Agency for Development Cooperation | |
dc.description.funder | University of North Carolina at Chapel Hill | |
dc.description.funder | University of Arizona | |
dc.description.funder | University of Pittsburgh | |
dc.description.funder | Agency for Health Care Research and Quality | |
dc.description.funder | Canadian Institutes of Health Research | |
dc.description.funder | Ontario HIV Treatment Network | |
dc.description.funder | Michael Smith Foundation for Health Research | |
dc.description.funder | Australian Research Council | |
dc.description.funder | Chinese National Natural Science Foundation | |
dc.description.funder | Ministry of Education of the Republic of Korea | |
dc.description.funder | National Research Foundation of Korea | |
dc.description.funder | China Scholarship Council | |
dc.description.funder | UPMC | |
dc.description.funder | Geneva University Hospitals | |
dc.format.extent | 133 páginas | |
dc.fuente.origen | Scopus | |
dc.identifier.doi | 10.5935/0103-507X.20220004 | |
dc.identifier.eissn | 19824335 | |
dc.identifier.issn | 0103507X | |
dc.identifier.pubmedid | 35766659 | |
dc.identifier.scieloid | S0718-69242020000300109 | |
dc.identifier.scopusid | SCOPUS_ID:85131238519 | |
dc.identifier.uri | https://doi.org/10.5935/0103-507X.20220004 | |
dc.identifier.uri | https://repositorio.uc.cl/handle/11534/103667 | |
dc.identifier.wosid | WOS:000804126100018 | |
dc.information.autoruc | Escuela de Medicina; Castro Lopez Ricardo Adolfo; 0000-0002-0978-9891; 4537 | |
dc.information.autoruc | Escuela de Medicina; Kattan Tala Eduardo Jose; 0000-0002-1997-6893; 172152 | |
dc.information.autoruc | Escuela de Medicina; Hernandez Poblete Glenn Wilson; 0000-0002-3032-4087; 98874 | |
dc.issue.numero | 1 | |
dc.language.iso | en | |
dc.nota.acceso | Sin adjunto | |
dc.pagina.final | 133 | |
dc.pagina.inicio | 97 | |
dc.relation.ispartof | Revista Brasileira de Terapia Intensiva | |
dc.revista | Revista Brasileira de Terapia Intensiva | |
dc.rights | Acceso abierto | |
dc.subject | Algorithm | |
dc.subject | Capillary refill time | |
dc.subject | Critical care | |
dc.subject | Echocardiography | |
dc.subject | Length of stay | |
dc.subject | Norepinephrine | |
dc.subject | Perfusion | |
dc.subject | Phenotype | |
dc.subject | Sepsis | |
dc.subject | Septic shock | |
dc.subject.ddc | 620 | |
dc.subject.dewey | Ingeniería | es_ES |
dc.subject.ods | 11 Sustainable cities and communities | |
dc.subject.odspa | 11 Ciudades y comunidades sostenibles | |
dc.title | Hemodynamic phenotype-based, capillary refill time-targeted resuscitation in early septic shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial study protocol | |
dc.type | artículo | |
dc.volumen | 34 | |
sipa.codpersvinculados | 4537 | |
sipa.codpersvinculados | 172152 | |
sipa.codpersvinculados | 98874 | |
sipa.index | Scopus | |
sipa.trazabilidad | Carga WOS-SCOPUS;01-05-2025 |