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Personalized Hemodynamic Resuscitation Targeting Capillary Refill Time in Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial

Fecha de publicación:

Autores de IIS La Fe

Participantes ajenos a IIS La Fe

  • Hernandez G.
  • Ospina-Tascón G.A.
  • Kattan E.
  • Ibarra-Estrada M.
  • Ramasco F.
  • Orozco N.
  • Ramos K.
  • Aldana J.L.
  • Ferri G.
  • Hamzaoui O.
  • De Backer D.
  • Teboul J.-L.
  • Vieillard-Baron A.
  • Petri Damiani L.
  • García-Gallardo G.A.
  • Morales S.
  • Mendez R.
  • Hernandez-Gilsoul T.
  • Pérez-Nieto O.R.
  • Olea Vielba C.
  • Ramos S.
  • Dominguez D.
  • Bruna M.
  • David S.
  • Wendel-Garcia P.D.
  • Galiana-Ivars M.
  • Myatra S.N.
  • Messina A.
  • Cecconi M.
  • Pozo M.
  • Amthauer M.
  • Higuera E.
  • Al Duhalib Z.
  • Rico-Feijoo J.
  • Ferrer-Gómez C.
  • Pérez-Carbonell A.
  • Martinez-Castro S.
  • Redondo Calvo F.J.
  • Vives M.
  • Sanchez H.F.
  • Bilbao I.
  • Fernandez P.
  • Al-Fares A.
  • Benitez-Cano A.
  • Gonzalez C.
  • Reyes L.F.
  • Rodriguez-Guillen J.H.
  • Cristino A.V.
  • Pendino J.C.
  • Ortiz G.
  • Alonso-Gonzalez M.C.
  • Murias G.
  • Aguirre-Ávalos G.
  • Hernández L.
  • Calderón Barajas Z.A.
  • Zarragoikoetxea I.
  • Monnet X.
  • Goury A.
  • Mendonça Dos Santos T.
  • Vallecilla L.
  • Martins De Lima L.
  • Sady E.
  • Alegria L.
  • Ostermann M.
  • Bakker J.
  • Biasi Cavalcanti A.

Grupos

Abstract

Importance: The optimal strategy for hemodynamic resuscitation in early septic shock remains uncertain. Objective: To determine the effect of a personalized hemodynamic resuscitation protocol targeting capillary refill time (CRT-PHR) on a hierarchical composite outcome of mortality, duration of vital support, and length of hospital stay. Design, Setting, and Participants: This randomized clinical trial was conducted in 86 centers in 19 countries. Patients within the first 4 hours of septic shock were included between March 2022 and April 2025, with last follow-up in July 2025. Interventions: Patients were randomized to undergo CRT-PHR (n = 720), including assessment of pulse pressure, diastolic arterial pressure, fluid responsiveness, and bedside echocardiography, to tailor fluids, vasopressors, and inotropes, vs usual care (n = 747). Main Outcomes and Measures: The primary outcome was a hierarchical composite of mortality, duration of vital support (vasoactives, mechanical ventilation, and kidney replacement therapy), and length of hospital stay assessed at 28 days. A win ratio was calculated for the primary outcome by comparing all possible patient pairs, starting with the first event in the hierarchy and stratified by median APACHE (Acute Physiology and Chronic Health Evaluation) II score at admission. Secondary outcomes were mortality, vital support-free days, and length of hospital stay at 28 days. Results: From 1501 randomized patients, 1467 were included in the primary analysis (mean age, 66 [17] years; 43.3% female). There were 131131 wins (48.9%) in the CRT-PHR group vs 112787 (42.1%) in the usual care group for the hierarchical composite primary outcome, with a win ratio of 1.16 (95% CI, 1.02-1.33; P =.04). Individual wins for death were 19.1% vs 17.8%; duration of vital support, 26.4% vs 21.1%; and length of hospital stay, 3.4% vs 3.2% in the intervention vs usual care groups, respectively. Conclusions and Relevance: Among patients with early septic shock, a personalized hemodynamic resuscitation protocol targeting capillary refill time was superior to usual care for the primary composite outcome, primarily due to a lower duration of vital support. Trial Registration: ClinicalTrials.gov Identifier: NCT05057611. © 2025 American Medical Association.

Datos de la publicación

ISSN/ISSNe:
0098-7484, 1538-3598

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION  AMER MEDICAL ASSOC

Tipo:
Article
Páginas:
1988-1999
PubMed:
41159835
Enlace a otro recurso:
www.scopus.com
Factor de Impacto:
6,076 SCImago ℠
Cuartil:
Q1 SCImago ℠

Citas Recibidas en Web of Science: 5

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Keywords

  • Aged; Capillaries; Cardiotonic Agents; Echocardiography; Female; Fluid Therapy; Hemodynamics; Humans; Length of Stay; Male; Middle Aged; Precision Medicine; Respiration, Artificial; Resuscitation; Shock, Septic; Vasoconstrictor Agents; dobutamine; hypertensive factor; inotropic agent; noradrenalin; cardiotonic agent; vasoconstrictor agent; aged; APACHE; arterial pressure; Article; artificial ventilation; capillary refill time; Charlson Comorbidity Index; clinician; controlled study; critically ill patient; diabetes mellitus; echocardiography; emergency ward; female; follow up; hemodynamics; high flow nasal cannula therapy; hospitalization; human; hypertension; hypovolemia; intensive care unit; invasive ventilation; length of stay; major clinical study; male; mediastinitis; medical parameters; multicenter study; noninvasive ventilation; outcome assessment; personalized medicine; pulse pressure; randomized controlled trial; renal replacement therapy; resuscitation; septic shock; Sequenti

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