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 Randomiz...

Autores
Hernández, Glenn; Ospina-Tascón, Gustavo A.; Petri Damiani, Lucas; 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 Virginia; Barahona, Diego; Granda-Luna, Vladimir; Biasi Cavalcanti, Alexandre; Bakker, Jan
Año de publicación
2019
Idioma
español castellano
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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.
Facultad de Ciencias Médicas
Materia
Ciencias Médicas
Peripheral perfusion
Septic shock
Resuscitation Strategy
Nivel de accesibilidad
acceso abierto
Condiciones de uso
http://creativecommons.org/licenses/by-nc-sa/4.0/
Repositorio
SEDICI (UNLP)
Institución
Universidad Nacional de La Plata
OAI Identificador
oai:sedici.unlp.edu.ar:10915/107704

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oai_identifier_str oai:sedici.unlp.edu.ar:10915/107704
network_acronym_str SEDICI
repository_id_str 1329
network_name_str SEDICI (UNLP)
spelling 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 TrialHernández, GlennOspina-Tascón, Gustavo A.Petri Damiani, LucasEstenssoro, ElisaDubin, ArnaldoHurtado, JavierFriedman, GilbertoCastro, RicardoAlegría, LeylaTeboul, Jean-LouisCecconi, MaurizioFerri, GiorgioJibaja, ManuelPairumani, RonaldFernández, Paula VirginiaBarahona, DiegoGranda-Luna, VladimirBiasi Cavalcanti, AlexandreBakker, JanCiencias MédicasPeripheral perfusionSeptic shockResuscitation Strategy<b>IMPORTANCE</b>: 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. <b>OBJECTIVE</b>: 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. <b>DESIGN, SETTING, AND PARTICIPANTS</b> 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. <b>INTERVENTIONS</b>: 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. <b>MAIN OUTCOMES AND MEASURES</b> 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. <b>RESULTS</b>: 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. <b>CONCLUSIONS AND RELEVANCE</b>: 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.Facultad de Ciencias Médicas2019info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionArticulohttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdf654-664http://sedici.unlp.edu.ar/handle/10915/107704spainfo:eu-repo/semantics/altIdentifier/url/http://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC6439620&blobtype=pdfinfo:eu-repo/semantics/altIdentifier/issn/0098-7484info:eu-repo/semantics/altIdentifier/pmid/30772908info:eu-repo/semantics/altIdentifier/doi/10.1001/jama.2019.0071info:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-sa/4.0/Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0)reponame:SEDICI (UNLP)instname:Universidad Nacional de La Platainstacron:UNLP2025-09-29T11:23:56Zoai:sedici.unlp.edu.ar:10915/107704Institucionalhttp://sedici.unlp.edu.ar/Universidad públicaNo correspondehttp://sedici.unlp.edu.ar/oai/snrdalira@sedici.unlp.edu.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:13292025-09-29 11:23:56.911SEDICI (UNLP) - Universidad Nacional de La Platafalse
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Ciencias Médicas
Peripheral perfusion
Septic shock
Resuscitation Strategy
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
dc.creator.none.fl_str_mv Hernández, Glenn
Ospina-Tascón, Gustavo A.
Petri Damiani, Lucas
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 Virginia
Barahona, Diego
Granda-Luna, Vladimir
Biasi Cavalcanti, Alexandre
Bakker, Jan
author Hernández, Glenn
author_facet Hernández, Glenn
Ospina-Tascón, Gustavo A.
Petri Damiani, Lucas
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 Virginia
Barahona, Diego
Granda-Luna, Vladimir
Biasi Cavalcanti, Alexandre
Bakker, Jan
author_role author
author2 Ospina-Tascón, Gustavo A.
Petri Damiani, Lucas
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 Virginia
Barahona, Diego
Granda-Luna, Vladimir
Biasi Cavalcanti, Alexandre
Bakker, Jan
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Ciencias Médicas
Peripheral perfusion
Septic shock
Resuscitation Strategy
topic Ciencias Médicas
Peripheral perfusion
Septic shock
Resuscitation Strategy
dc.description.none.fl_txt_mv <b>IMPORTANCE</b>: 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. <b>OBJECTIVE</b>: 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. <b>DESIGN, SETTING, AND PARTICIPANTS</b> 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. <b>INTERVENTIONS</b>: 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. <b>MAIN OUTCOMES AND MEASURES</b> 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. <b>RESULTS</b>: 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. <b>CONCLUSIONS AND RELEVANCE</b>: 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.
Facultad de Ciencias Médicas
description <b>IMPORTANCE</b>: 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. <b>OBJECTIVE</b>: 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. <b>DESIGN, SETTING, AND PARTICIPANTS</b> 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. <b>INTERVENTIONS</b>: 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. <b>MAIN OUTCOMES AND MEASURES</b> 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. <b>RESULTS</b>: 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. <b>CONCLUSIONS AND RELEVANCE</b>: 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.
publishDate 2019
dc.date.none.fl_str_mv 2019
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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info:eu-repo/semantics/altIdentifier/issn/0098-7484
info:eu-repo/semantics/altIdentifier/pmid/30772908
info:eu-repo/semantics/altIdentifier/doi/10.1001/jama.2019.0071
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
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