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

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 pi...
Ausführliche Beschreibung

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) Ausführliche Beschreibung

Autor*in:	Hernández, Glenn [verfasserIn] Cavalcanti, Alexandre Biasi [verfasserIn] Ospina-Tascón, Gustavo [verfasserIn] Zampieri, Fernando Godinho [verfasserIn] Dubin, Arnaldo [verfasserIn] Hurtado, F. Javier [verfasserIn] Friedman, Gilberto [verfasserIn] Castro, Ricardo [verfasserIn] Alegría, Leyla [verfasserIn] Cecconi, Maurizio [verfasserIn] Teboul, Jean-Louis [verfasserIn] Bakker, Jan [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2018

Schlagwörter:	Septic shock Resuscitation Peripheral perfusion Lactate Fluid responsiveness

Übergeordnetes Werk:	Enthalten in: Annals of intensive care - Heidelberg : Springer, 2011, 8(2018), 1 vom: 23. Apr.
Übergeordnetes Werk:	volume:8 ; year:2018 ; number:1 ; day:23 ; month:04

Links:	Volltext

DOI / URN:	10.1186/s13613-018-0398-2

Katalog-ID:	SPR03193174X