Title |
Early goal-directed therapy using a physiological holistic view: the ANDROMEDA-SHOCK—a randomized controlled trial
|
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Published in |
Annals of Intensive Care, April 2018
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DOI | 10.1186/s13613-018-0398-2 |
Pubmed ID | |
Authors |
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, The ANDROMEDA-SHOCK Study Investigators |
Abstract |
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. 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. 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). |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
United States | 5 | 23% |
United Kingdom | 4 | 18% |
Chile | 2 | 9% |
Denmark | 1 | 5% |
India | 1 | 5% |
Canada | 1 | 5% |
Malaysia | 1 | 5% |
Mexico | 1 | 5% |
Spain | 1 | 5% |
Other | 1 | 5% |
Unknown | 4 | 18% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 13 | 59% |
Practitioners (doctors, other healthcare professionals) | 6 | 27% |
Scientists | 2 | 9% |
Science communicators (journalists, bloggers, editors) | 1 | 5% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 159 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 18 | 11% |
Student > Postgraduate | 18 | 11% |
Other | 15 | 9% |
Student > Master | 15 | 9% |
Student > Ph. D. Student | 14 | 9% |
Other | 36 | 23% |
Unknown | 43 | 27% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 92 | 58% |
Nursing and Health Professions | 6 | 4% |
Social Sciences | 4 | 3% |
Computer Science | 2 | 1% |
Engineering | 2 | 1% |
Other | 5 | 3% |
Unknown | 48 | 30% |