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JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.

Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial.

Author information

1
Departmento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago.
2
Fundación Valle del Lili, Universidad ICESI, Department of Intensive Care Medicine, Cali, Colombia.
3
HCor Research Institute-Hospital do Coração, Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.
4
Hospital Interzonal de Agudos San Martín de La Plata, La Plata, Argentina.
5
Sanatorio Otamendi, Buenos Aires, Argentina.
6
Cátedra de Farmacología Aplicada, Facultad de Ciencias Médicas, Universidad Nacional de La Plata, La Plata, Argentina.
7
Intensive Care Unit, Hospital Español-ASSE, Montevideo, Uruguay.
8
Department of Pathophysiology, School of Medicine Universidad de la República, Montevideo, Uruguay.
9
Post-Graduation Program in Pneumological Sciences, Department of Internal Medicine, School of Medicine, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.
10
Service de Réanimation Médicale, Hopital Bicetre, Hopitaux Universitaires Paris-Sud, Paris, France.
11
Assistance Publique Hôpitaux de Paris, Université Paris-Sud, Paris, France.
12
Humanitas Clinical and Research Center, Department of Biomedical Sciences, Humanitas University, Milan, Italy.
13
Unidad de Cuidados Intensivos, Hospital Barros Luco Trudeau, Santiago, Chile.
14
Unidad de Cuidados Intensivos, Hospital Eugenio Espejo, Escuela de Medicina, Universidad Internacional del Ecuador, Quito.
15
Unidad de Pacientes Críticos, Hospital Guillermo Grant Benavente, Concepción, Chile.
16
Unidad de Cuidados Intensivos, Hospital General Docente de Calderón, Universidad Central del Ecuador, Quito.
17
Unidad de Cuidados Intensivos, Hospital San Francisco, Pontificia Universidad Católica de Quito, Quito, Ecuador.
18
Department of Intensive Care Adults, Erasmus MC University Medical Center, Rotterdam, the Netherlands.
19
Department of Pulmonary and Critical Care, New York University, New York, New York.
20
Division of Pulmonary, Allergy, and Critical Care Medicine, Columbia University Medical Center, New York, New York.

Abstract

Importance:

Abnormal peripheral perfusion after septic shock resuscitation has been associated with organ dysfunction and mortality. The potential role of the clinical assessment of peripheral perfusion as a target during resuscitation in early septic shock has not been established.

Objective:

To determine if a peripheral perfusion-targeted resuscitation during early septic shock in adults is more effective than a lactate level-targeted resuscitation for reducing mortality.

Design, Setting, and Participants:

Multicenter, randomized trial conducted at 28 intensive care units in 5 countries. Four-hundred twenty-four patients with septic shock were included between March 2017 and March 2018. The last date of follow-up was June 12, 2018.

Interventions:

Patients were randomized to a step-by-step resuscitation protocol aimed at either normalizing capillary refill time (n = 212) or normalizing or decreasing lactate levels at rates greater than 20% per 2 hours (n = 212), during an 8-hour intervention period.

Main Outcomes and Measures:

The primary outcome was all-cause mortality at 28 days. Secondary outcomes were organ dysfunction at 72 hours after randomization, as assessed by Sequential Organ Failure Assessment (SOFA) score (range, 0 [best] to 24 [worst]); death within 90 days; mechanical ventilation-, renal replacement therapy-, and vasopressor-free days within 28 days; intensive care unit and hospital length of stay.

Results:

Among 424 patients randomized (mean age, 63 years; 226 [53%] women), 416 (98%) completed the trial. By day 28, 74 patients (34.9%) in the peripheral perfusion group and 92 patients (43.4%) in the lactate group had died (hazard ratio, 0.75 [95% CI, 0.55 to 1.02]; P = .06; risk difference, -8.5% [95% CI, -18.2% to 1.2%]). Peripheral perfusion-targeted resuscitation was associated with less organ dysfunction at 72 hours (mean SOFA score, 5.6 [SD, 4.3] vs 6.6 [SD, 4.7]; mean difference, -1.00 [95% CI, -1.97 to -0.02]; P = .045). There were no significant differences in the other 6 secondary outcomes. No protocol-related serious adverse reactions were confirmed.

Conclusions and Relevance:

Among patients with septic shock, a resuscitation strategy targeting normalization of capillary refill time, compared with a strategy targeting serum lactate levels, did not reduce all-cause 28-day mortality.

Trial Registration:

ClinicalTrials.gov Identifier: NCT03078712.

PMID:
30772908
PMCID:
PMC6439620
[Available on 2019-08-17]
DOI:
10.1001/jama.2019.0071
[Indexed for MEDLINE]

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