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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.

Hernández, Glenn; Ospina-Tascón, Gustavo A; Damiani, Lucas Petri; Estenssoro, Elisa; Dubin, Arnaldo; Hurtado, Javier; Friedman, Gilberto; Castro, Ricardo; Alegría, Leyla; Teboul, Jean-Louis; Cecconi, Maurizio; Ferri, Giorgio; Jibaja, Manuel; Pairumani, Ronald; Fernández, Paula; Barahona, Diego; Granda-Luna, Vladimir; Cavalcanti, Alexandre Biasi; Bakker, Jan; Hernández, Glenn; Ospina-Tascón, Gustavo; Petri Damiani, Lucas; Estenssoro, Elisa; Dubin, Arnaldo; Hurtado, Javier; Friedman, Gilberto; Castro, Ricardo; Alegría, Leyla; Teboul, Jean-Louis; Cecconi, Maurizio; Cecconi, Maurizio; Ferri, Giorgio; Jibaja, Manuel; Pairumani, Ronald; Fernández, Paula; Barahona, Diego; Cavalcanti, Alexandre Biasi; Bakker, Jan; Hernández, Glenn; Alegría, Leyla; Ferri, Giorgio; Rodriguez, Nicolás; Holger, Patricia; Soto, Natalia; Pozo, Mario; Bakker, Jan; Cook, Deborah; Vincent, Jean-Louis; Rhodes, Andrew; Kavanagh, Bryan P.
JAMA; 321(7): 654-664, 2019 02 19.
Artigo em Inglês | MEDLINE | Fev 2019 | ID: mdl-30772908
Resumo: 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.