Early goal directed therapy using a physiological holistic view : the ANDROMEDA SHOCK—a randomized controlled trial

• Autor(a) principal: Hernandez Poblete, Glenn Wilson
• Data de Publicação: 2018
• Outros Autores: Cavalcanti, Alexandre Biasi, Ospina-Tascón, Gustavo Adolfo, Zampieri, Fernando Godinho, Dubin, Arnaldo, Hurtado Bredda, Francisco Javier, Friedman, Gilberto, Castro Lopez, Ricardo Adolfo, Alegria Vargas, Leyla Morelia, Cecconi, Maurizio, Teboul, Jean-Louis, Bakker, Jan, The ANDROMEDA-SHOCK Study Investigators
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UFRGS
• Texto Completo: http://hdl.handle.net/10183/180083
• topic: Choque séptico; Ressuscitação; Reperfusão miocárdica; Deslocamentos de líquidos corporais; Ácido láctico; Septic shock; Resuscitation; Peripheral perfusion; Lactate; Fluid responsiveness

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 perfusiontargeted 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.