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Hernández G, Cavalcanti AB, Ospina-Tascón G, et al. Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK-a randomized controlled trial. Ann Intensive Care. 2018;8(1):52doi: 10.1186/s13613-018-0398-2.
Hernández, G., Cavalcanti, A. B., Ospina-Tascón, G., Zampieri, F. G., Dubin, A., Hurtado, F. J., Friedman, G., Castro, R., Alegría, L., Cecconi, M., Teboul, J. L., Bakker, J. (2018). Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK-a randomized controlled trial. Annals of intensive care, 8(1), 52. https://doi.org/10.1186/s13613-018-0398-2
Hernández, Glenn, et al. "Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK-a randomized controlled trial." Annals of intensive care vol. 8,1 (2018): 52. doi: https://doi.org/10.1186/s13613-018-0398-2
Hernández G, Cavalcanti AB, Ospina-Tascón G, Zampieri FG, Dubin A, Hurtado FJ, Friedman G, Castro R, Alegría L, Cecconi M, Teboul JL, Bakker J. Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK-a randomized controlled trial. Ann Intensive Care. 2018 Apr 23;8(1):52. doi: 10.1186/s13613-018-0398-2. PMID: 29687277; PMCID: PMC5913056.
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Ann Intensive Care. 2018 Apr 23;8(1):52. doi: 10.1186/s13613-018-0398-2.

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

Annals of intensive care

Glenn Hernández, Alexandre Biasi Cavalcanti, Gustavo Ospina-Tascón, Fernando Godinho Zampieri, Arnaldo Dubin, F Javier Hurtado, Gilberto Friedman, Ricardo Castro, Leyla Alegría, Maurizio Cecconi, Jean-Louis Teboul, Jan Bakker,

Affiliations

  1. Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile. [email protected].
  2. Research Institute HCor, Hospital do Coração, R. Des. Eliseu Guilherme, 147 - Paraíso, São Paulo, Brazil.
  3. Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICESI, Carrera 98 # 18-49, Cali, Colombia.
  4. Servicio de Terapia Intensiva, Sanatorio Otamendi y Miroli, Azcuénaga 894, Ciudad Autónoma de Buenos Aires, Argentina.
  5. Centro de Tratamiento Intensivo, Hospital Español, Escuela de Medicina, Universidad de la República, Avda. Gral. Garibaldi, 1729 esq. Rocha, Montevideo, Uruguay.
  6. Departamento de Medicina Interna, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul, R. Ramiro Barcelos 2350 - Santa Cecilia, Porto Alegre, Brazil.
  7. Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Diagonal Paraguay 362, Santiago, Chile.
  8. St George's University Hospitals NHS Foundation Trust, Rd, London, SW17 0QT, UK.
  9. Service de Réanimation médicale, Hôpitaux universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris, Paris, France.
  10. Division of Pulmonary, Allergy and Critical Care Medicine, Columbia University Medical Center, 630 W 168th St, New York, USA.
  11. Department Intensive Care Adults, Erasmus MC University Medical Center, Rotterdam, CA, The Netherlands.
  12. Division of Pulmonary, and Critical Care Medicine, New York University-Langone, New York, USA.

PMID: 29687277 PMCID: PMC5913056 DOI: 10.1186/s13613-018-0398-2

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).

Keywords: Fluid responsiveness; Lactate; Peripheral perfusion; Resuscitation; Septic shock

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