Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial.

Glenn Hernández, Gustavo A Ospina-Tascón, Lucas Petri Damiani, Elisa Estenssoro, Arnaldo Dubin, Javier Hurtado, Gilberto Friedman, Ricardo Castro, Leyla Alegría, Jean-Louis Teboul, Maurizio Cecconi, Giorgio Ferri, Manuel Jibaja, Ronald Pairumani, Paula Fernández, Diego Barahona, Vladimir Granda-Luna, Alexandre Biasi Cavalcanti, Jan Bakker, Glenn Hernández, Gustavo Ospina-Tascón, Lucas Petri Damiani, Elisa Estenssoro, Arnaldo Dubin, Javier Hurtado, Gilberto Friedman, Ricardo Castro, Leyla Alegría, Jean-Louis Teboul, Maurizio Cecconi, Maurizio Cecconi, Giorgio Ferri, Manuel Jibaja, Ronald Pairumani, Paula Fernández, Diego Barahona, Alexandre Biasi Cavalcanti, Jan Bakker, Glenn Hernández, Leyla Alegría, Giorgio Ferri, Nicolás Rodriguez, Patricia Holger, Natalia Soto, Mario Pozo, Jan Bakker, Deborah Cook, Jean-Louis Vincent, Andrew Rhodes, Bryan P Kavanagh, Phil Dellinger, Wim Rietdijk, David Carpio, Nicolás Pavéz, Elizabeth Henriquez, Sebastian Bravo, Emilio Daniel Valenzuela, Magdalena Vera, Jorge Dreyse, Vanessa Oviedo, Maria Alicia Cid, Macarena Larroulet, Edward Petruska, Claudio Sarabia, David Gallardo, Juan Eduardo Sanchez, Hugo González, José Miguel Arancibia, Alex Muñoz, Germán Ramirez, Florencia Aravena, Andrés Aquevedo, Fabián Zambrano, Milan Bozinovic, Felipe Valle, Manuel Ramirez, Victor Rossel, Pilar Muñoz, Carolina Ceballos, Christian Esveile, Cristian Carmona, Eva Candia, Daniela Mendoza, Aída Sanchez, Daniela Ponce, Daniela Ponce, Jaime Lastra, Bárbara Nahuelpán, Fabrizio Fasce, Cecilia Luengo, Nicolas Medel, Cesar Cortés, Luz Campassi, Paolo Rubatto, Nahime Horna, Mariano Furche, Juan Carlos Pendino, Lisandro Bettini, Carlos Lovesio, María Cecilia González, Jésica Rodruguez, Héctor Canales, Francisco Caminos, Cayetano Galletti, Estefanía Minoldo, Maria Jose Aramburu, Daniela Olmos, Nicolás Nin, Jordán Tenzi, Carlos Quiroga, Pablo Lacuesta, Agustín Gaudín, Richard Pais, Ana Silvestre, Germán Olivera, Gloria Rieppi, Dolores Berrutti, Marcelo Ochoa, Paul Cobos, Fernando Vintimilla, Vanessa Ramirez, Milton Tobar, Fernanda García, Fabricio Picoita, Nelson Remache, Vladimir Granda, Fernando Paredes, Eduardo Barzallo, Paul Garcés, Fausto Guerrero, Santiago Salazar, German Torres, Cristian Tana, José Calahorrano, Freddy Solis, Pedro Torres, Luís Herrera, Antonio Ornes, Verónica Peréz, Glenda Delgado, Alexei López, Eliana Espinosa, José Moreira, Blanca Salcedo, Ivonne Villacres, Jhonny Suing, Marco Lopez, Luis Gomez, Guillermo Toctaquiza, Mario Cadena Zapata, Milton Alonso Orazabal, Ruben Pardo Espejo, Jorge Jimenez, Alexander Calderón, Gustavo Paredes, José Luis Barberán, Tatiana Moya, Horacio Atehortua, Rodolfo Sabogal, Guillermo Ortiz, Antonio Lara, Fabio Sanchez, Alvaro Hernán Portilla, Humberto Dávila, Jorge Antonio Mora, Luis Eduardo Calderón, Ingrid Alvarez, Elena Escobar, Alejandro Bejarano, Luis Alfonso Bustamante, José Luis Aldana

JAMA 2019 Februrary 20

IMPORTANCE: Abnormal peripheral perfusion after septic shock resuscitation has been associated with organ dysfunction and mortality. The potential role of the clinical assessment of peripheral perfusion as a target during resuscitation in early septic shock has not been established.

OBJECTIVE: To determine if a peripheral perfusion-targeted resuscitation during early septic shock in adults is more effective than a lactate level-targeted resuscitation for reducing mortality.

DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized trial conducted at 28 intensive care units in 5 countries. Four-hundred twenty-four patients with septic shock were included between March 2017 and March 2018. The last date of follow-up was June 12, 2018.

INTERVENTIONS: Patients were randomized to a step-by-step resuscitation protocol aimed at either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.

MAIN OUTCOMES AND MEASURES: The primary outcome was all-cause mortality at 28 days. Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]); death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.

RESULTS: Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, -8.5% [95% CI, -18.2% to 1.2%]). Peripheral perfusion-targeted resuscitation was associated with less organ dysfunction at 72 hours (mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, -1.00 [95% CI, -1.97 to -0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes. No protocol-related serious adverse reactions were confirmed.

CONCLUSIONS AND RELEVANCE: Among patients with septic shock, a resuscitation strategy targeting normalization of capillary refill time, compared with a strategy targeting serum lactate levels, did not reduce all-cause 28-day mortality.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03078712.

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