Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK—a randomized controlled trial - 08/01/26
, Alexandre Biasi Cavalcanti 2 , Gustavo Ospina-Tascón 3 , Fernando Godinho Zampieri 2 , Arnaldo Dubin 4 , F. Javier Hurtado 5 , Gilberto Friedman 6, Ricardo Castro 1 , Leyla Alegría 1 , Maurizio Cecconi 7 , Jean-Louis Teboul 8 , Jan Bakker 1, 9, 10, 11 The ANDROMEDA-SHOCK Study Investigators
Glenn Hernandez, Gustavo Ospina-Tascón, Alexandre Cavalcanti, Arnaldo Dubin, Javier Hurtado, Gilberto Friedman, Ricardo Castro, Leyla Alegría, Jean-Louis Teboul, Maurizio Cecconi, Fernando Zampieri, Lucas Petri Damiani, Jan Bakker, Giorgio Ferri, Nicolás Rodriguez, Patricia Holger, Natalia Soto, Mario Pozo, Deborah Cook, Jean-Louis Vincent, Andrew Rhodes, Bryan Kavanagh, Phil Dellinger, Wim Rietdijk, David Carpio, Nicolás Pavéz, Elizabeth Henriquez, Sebastian Bravo, Emilio Daniel Valenzuela, Maria Alicia Cid, Ronald Pairumani, 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, Paula Fernández, Daniela Ponce, Jaime Lastra, Bárbara Nahuelpán, Fabrizio Fasce, Cecilia Luengo, Nicolas Medel, Cesar Cortés, Luz Campassi, Paolo Rubatto, Brenda Nahime Horna, Mariano Furche, Juan Carlos Pendino, Lisandro Bettini, Carlos Lovesio, María Cecilia González, Jésica Rodruguez, Elisa Estenssoro, Héctor Canales, Francisco Caminos, Cayetano Galletti, Estefanía Minoldo, María José 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, Manuel Jibaja, 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 Carbonell, Eliana Espinosa, José Moreira, Diego Barahona, 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, Gustavo Ospina-Tascón, Luis Eduardo Calderón, Ingrid Alvarez, Elena Escobar, Alejandro Bejarano, Luis Alfonso Bustamante
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Abstract |
Background |
Septic shock is a highly lethal condition. Early recognition of tissue hypoperfusion and its reversion are key factors for limiting progression to multiple organ dysfunction and death. Lactate-targeted resuscitation is the gold-standard under current guidelines, although it has several pitfalls including that non-hypoxic sources of lactate might predominate in an unknown proportion of patients. Peripheral perfusion-targeted resuscitation might provide a real-time response to increases in flow that could lead to a more timely decision to stop resuscitation, thus avoiding fluid overload and the risks of over-resuscitation. This article reports the rationale, study design and analysis plan of the ANDROMEDA-SHOCK Study.
Methods |
ANDROMEDA-SHOCK is a randomized controlled trial which aims to determine if a peripheral perfusion-targeted resuscitation is associated with lower 28-day mortality compared to a lactate-targeted resuscitation in patients with septic shock with less than 4 h of diagnosis. Both groups will be treated with the same sequential approach during the 8-hour study period pursuing normalization of capillary refill time versus normalization or a decrease of more than 20% of lactate every 2 h. The common protocol starts with fluid responsiveness assessment and fluid loading in responders, followed by a vasopressor and an inodilator test if necessary. The primary outcome is 28-day mortality, and the secondary outcomes are: free days of mechanical ventilation, renal replacement therapy and vasopressor support during the first 28 days after randomization; multiple organ dysfunction during the first 72 h after randomization; intensive care unit and hospital lengths of stay; and all-cause mortality at 90-day. A sample size of 422 patients was calculated to detect a 15% absolute reduction in mortality in the peripheral perfusion group with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle.
Conclusions |
If peripheral perfusion-targeted resuscitation improves 28-day mortality, this could lead to simplified algorithms, assessing almost in real-time the reperfusion process, and pursuing more physiologically sound objectives. At the end, it might prevent the risk of over-resuscitation and lead to a better utilization of intensive care unit resources.
Trial registration ClinicalTrials.gov Identifier: NCT03078712 (registered retrospectively March 13th, 2017)
Le texte complet de cet article est disponible en PDF.Keywords : Septic shock, Resuscitation, Peripheral perfusion, Lactate, Fluid responsiveness
Plan
Vol 8 - N° 1
Article 52- 2018 Retour au numéro
Article précédent
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