Personalized Hemodynamic Resuscitation Targeting Capillary Refill Time in Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial
- Autori: Glenn, H.; Gustavo A, O.; Eduardo, K.; Miguel, I.; Fernando, R.; Nicolás, O.; Karla, R.; Jose Luis, A.; Giorgio, F.; Olfa, H.; Daniel, D.B.; Jean-Louis, T.; Antoine, V.; Lucas, P.D.; Gustavo A, G.; Sebastian, M.; Paula, C.G.; Rosa, M.; Thierry, H.; Orlando R, P.; Claudia, O.V.; Silvia, R.; David, D.; Mario, B.; Sascha, D.; Pedro D, W.; María, G.; Sheila Nainan, M.; Antonio, M.; Maurizio, C.; Mario, P.; Macarena, A.; Eva, H.; Zainab, A.D.; Jesús, R.; Carolina, F.; Ana, P.; Sara, M.; Francisco Javier, R.C.; Marc, V.; Hector Fabio, S.; Iñaki, B.; Paula, F.; Abdulrahman, A.; Adela, B.; Cecilia, G.; Luis Felipe, R.; Job H, R.; Ana Vaz, C.; Juan Carlos, P.; Guillermo, O.; Maria Concepción, A.; Gastón, M.; Guadalupe, A.; Leonardo, H.; Zulay Adriana, C.B.; Iratxe, Z.; Xavier, M.; Antoine, G.; Tiago, M.D.S.; Liliana, V.; Lucas, M.D.L.; Erica, S.; Leyla, A.; Marlies, O.; Jan, B.; Alexandre, B.C.; Investigators For The Andromeda Research Network, A.; Society Of Anesthesiology, S.; and Pain Therapy (SEDAR), R.; Latin American Intensive Care Network (LIVEN): Fernando Pálizas, A.; Lattanzio, B.; Durandal, N.; Eugenia Alonso, M.; Duque, J.; Falcon, N.; Mesa, R.; Hunter, M.; Pozo, M.; Gutierrez, F.; Sac, S.; Goette, N.; Consalvo, S.; Zamudio, P.; Murias, G.; Carlos Pendino, J.; Bettini, L.; Ignacio Ibarzabal, J.; Torres, V.; Fiorilli, F.; Sacchi, W.; Avila, V.; Gonzalez, C.; Traverso, A.; Lopipi, A.; Sterzer, G.; Rodriguez Louzan, J.; Estenssoro, E.; Dubin, A.; Westphal, G.; Liguori, M.; Tramujas, L.; Piotto, B.; Romano, M.; Medrano, F.; Rola, P.; Prager, R.; Basmaji, J.; Ferri, G.; Hernández, L.; Amigo, D.; Barra, A.; Coba, C.; Valdivia, L.; Pablo Valdivia, J.; Petruska, E.; Noguera, R.; Sarabia, C.; Alicia Cid, M.; Tapia, J.; Gonzalez, F.; Morales, F.; Gomez, A.; Yarur, C.; Segura, J.; Rosales, R.; Pairumani, R.; Araya, C.; Cañon, E.; Vera, M.; Larroulet, M.; Gallo, C.; Mero, C.; Nicolas Medel, J.; Cornejo, R.; Montoya, J.; Carreño, N.; Illanes, V.; Cortés, C.; Amthauer, M.; Gonzalez Almonacid, C.; Valerie Philp Sandoval, R.; Javier Castillo Bascur, P.; Andrés Colima Mendoza, R.; Beatriz Espinoza Casado, C.; Enrique Morales Valenzuela, J.; Orellana Naranjo, V.; Enrique Chavez Medina, C.; Santiago López Valladares, P.; César Melo Alarcón, P.; Andrés Hernández Diaz, M.; Manuel Vallejos Rubilar, V.; Chinchon, E.; Valenzuela, E.; Oviedo, V.; Castro, R.; Ulloa, R.; Bravo Morales, S.; Contreras Aguilera, R.; Mondaca, R.; Retamal, J.; Bruhn, A.; Aguilera, P.; Pablo Blanco, J.; Santis, C.; Basoalto, R.; Uribe Copier, P.; Godoy Juárez, C.; Bruna, M.; Alfaro, S.; Conlledo, R.; Cisternas, L.; Urbina, C.; Toledo, V.; Fernandez, P.; Pavez Paredes, N.; Gallardo, D.; Miguel Arancibia Henríquez, J.; Aravena Ibáñez, F.; Caniguante Barco, G.; Lobo Villarroel, N.; Muñoz Morales, A.; Ramírez Machuca, G.; Rojas Vargas, J.; Luis Valenzuela Cruz, J.; Ebner Álvarez, M.; E Sánchez Valenzuela, J.; Gómez Cornejo, C.; Bustamante Garmendia, C.; Felipe Reyes Velasco, L.; Camilo Serrano, C.; Carvajal, K.; Leonardo Cáceres, E.; María Crispin Aldana, A.; Daniela Ibáñez, E.; González, A.; Patricia González Perilla, G.; Leonardo Rodriguez, O.; Olivella Gomez, J.; Molina, F.; Ochoa, A.; Rodas, D.; Blandón, C.; Carlos Álvarez, L.; Poveda, C.; Fernando Bautista, D.; Vargas, M.; Zarama, V.; Escobar, E.; Diez, J.; Carvajal, S.; Vargas, C.; Camila Arango, M.; Armando Revelo, J.; Díaz, C.; Umaña, M.; García, A.; Medina, C.; Cristina Florián Pérez, M.; David Caicedo Buitrago, N.; Mora, S.; Giraldo, N.; Ortiz, G.; Augusto Celemin, C.; Katherine Alfonso Gamboa, D.; Cortes Bravo, A.; Andres Garay, M.; Iván Rodríguez Castro, N.; Andres Rojas, C.; Alexander Guezguan, J.; Lara García, A.; Alberto Marín, C.; Marquez Galindo, M.; Adolfo Suarez Cárdenas, D.; Elena Llinás Medina, Y.; Fabio Sanchez, H.; Rojas, C.; Solarte, M.; Martinez, D.; Melendez, A.; Lozano, D.; Milton, E.; Enrriquez, J.; Granda Luna, V.; Escola Brito, A.; Jativa Baquero, M
- Anno di pubblicazione: 2025
- Tipologia: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/692527
Abstract
Importance: The optimal strategy for hemodynamic resuscitation in early septic shock remains uncertain. Objective: To determine the effect of a personalized hemodynamic resuscitation protocol targeting capillary refill time (CRT-PHR) on a hierarchical composite outcome of mortality, duration of vital support, and length of hospital stay. Design, setting, and participants: This randomized clinical trial was conducted in 86 centers in 19 countries. Patients within the first 4 hours of septic shock were included between March 2022 and April 2025, with last follow-up in July 2025. Interventions: Patients were randomized to undergo CRT-PHR (n = 720), including assessment of pulse pressure, diastolic arterial pressure, fluid responsiveness, and bedside echocardiography, to tailor fluids, vasopressors, and inotropes, vs usual care (n = 747). Main outcomes and measures: The primary outcome was a hierarchical composite of mortality, duration of vital support (vasoactives, mechanical ventilation, and kidney replacement therapy), and length of hospital stay assessed at 28 days. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy and stratified by median APACHE (Acute Physiology and Chronic Health Evaluation) II score at admission. Secondary outcomes were mortality, vital support-free days, and length of hospital stay at 28 days. Results: From 1501 randomized patients, 1467 were included in the primary analysis (mean age, 66 [17] years; 43.3% female). There were 131 131 wins (48.9%) in the CRT-PHR group vs 112 787 (42.1%) in the usual care group for the hierarchical composite primary outcome, with a win ratio of 1.16 (95% CI, 1.02-1.33; P = .04). Individual wins for death were 19.1% vs 17.8%; duration of vital support, 26.4% vs 21.1%; and length of hospital stay, 3.4% vs 3.2% in the intervention vs usual care groups, respectively. Conclusions and relevance: Among patients with early septic shock, a personalized hemodynamic resuscitation protocol targeting capillary refill time was superior to usual care for the primary composite outcome, primarily due to a lower duration of vital support. Trial registration: ClinicalTrials.gov Identifier: NCT05057611.