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

Annals of Intensive Care. 2018;8(1):1-10 DOI 10.1186/s13613-018-0398-2

 

Journal Homepage

Journal Title: Annals of Intensive Care

ISSN: 2110-5820 (Online)

Publisher: SpringerOpen

Society/Institution: French Intensive Care Society

LCC Subject Category: Medicine: Internal medicine: Medical emergencies. Critical care. Intensive care. First aid

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS


Glenn Hernández (Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile)

Alexandre Biasi Cavalcanti (Research Institute HCor, Hospital do Coração)

Gustavo Ospina-Tascón (Department of Intensive Care Medicine, Fundación Valle del Lili, Universidad ICESI)

Fernando Godinho Zampieri (Research Institute HCor, Hospital do Coração)

Arnaldo Dubin (Servicio de Terapia Intensiva, Sanatorio Otamendi y Miroli)

F. Javier Hurtado (Centro de Tratamiento Intensivo, Hospital Español, Escuela de Medicina, Universidad de la República)

Gilberto Friedman (Departamento de Medicina Interna, Faculdade de Medicina, Universidade Federal do Rio Grande do Sul)

Ricardo Castro (Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile)

Leyla Alegría (Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile)

Maurizio Cecconi (St George’s University Hospitals NHS Foundation Trust)

Jean-Louis Teboul (Service de Réanimation médicale, Hôpitaux universitaires Paris-Sud, Assistance Publique-Hôpitaux de Paris)

Jan Bakker (Departamento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile)

The ANDROMEDA-SHOCK Study Investigators

EDITORIAL INFORMATION

Blind peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 13 weeks

 

Abstract | Full Text

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)