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Early goal directed therapy using a physiological holistic view : the ANDROMEDA SHOCK—a randomized controlled trial
dc.contributor.author | Hernandez Poblete, Glenn Wilson | pt_BR |
dc.contributor.author | Cavalcanti, Alexandre Biasi | pt_BR |
dc.contributor.author | Ospina-Tascón, Gustavo Adolfo | pt_BR |
dc.contributor.author | Zampieri, Fernando Godinho | pt_BR |
dc.contributor.author | Dubin, Arnaldo | pt_BR |
dc.contributor.author | Hurtado Bredda, Francisco Javier | pt_BR |
dc.contributor.author | Friedman, Gilberto | pt_BR |
dc.contributor.author | Castro Lopez, Ricardo Adolfo | pt_BR |
dc.contributor.author | Alegria Vargas, Leyla Morelia | pt_BR |
dc.contributor.author | Cecconi, Maurizio | pt_BR |
dc.contributor.author | Teboul, Jean-Louis | pt_BR |
dc.contributor.author | Bakker, Jan | pt_BR |
dc.contributor.author | The ANDROMEDA-SHOCK Study Investigators | pt_BR |
dc.date.accessioned | 2018-07-04T02:27:22Z | pt_BR |
dc.date.issued | 2018 | pt_BR |
dc.identifier.issn | 2110-5820 | pt_BR |
dc.identifier.uri | http://hdl.handle.net/10183/180083 | pt_BR |
dc.description.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 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. | en |
dc.format.mimetype | application/pdf | pt_BR |
dc.language.iso | eng | pt_BR |
dc.relation.ispartof | Annals of intensive care. Heidelberg : Springer-Verlag, 2011-. Vol. 8 (2018), 10 f. | pt_BR |
dc.rights | Open Access | en |
dc.subject | Septic shock | en |
dc.subject | Choque séptico | pt_BR |
dc.subject | Ressuscitação | pt_BR |
dc.subject | Resuscitation | en |
dc.subject | Peripheral perfusion | en |
dc.subject | Reperfusão miocárdica | pt_BR |
dc.subject | Deslocamentos de líquidos corporais | pt_BR |
dc.subject | Lactate | en |
dc.subject | Ácido láctico | pt_BR |
dc.subject | Fluid responsiveness | en |
dc.title | Early goal directed therapy using a physiological holistic view : the ANDROMEDA SHOCK—a randomized controlled trial | pt_BR |
dc.type | Artigo de periódico | pt_BR |
dc.identifier.nrb | 001070298 | pt_BR |
dc.type.origin | Estrangeiro | pt_BR |
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