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
Open accessAbstract
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.
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At day 3, the CRT group had significantly less organ dysfunction as assessed by SOFA score (mean SOFA score 5.6 [SD 4.3] versus 6.6 [SD 4.7]; p = 0.045).
“At day 3, the CRT group had significantly less organ dysfunction as assessed by SOFA score (mean SOFA score 5.6 [SD 4.3] versus 6.6 [SD 4.7]; p = 0.045).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [58]
Twenty-eight-day mortality was 34.9% in the peripheral perfusion group and 43.4% in the lactate group, but this difference did not reach statistical significance (HR, 0.75; 95% CI, 0.55-1.02).
“Twenty-eight-day mortality was 34.9% in the peripheral perfusion group and 43.4% in the lactate group, but this difference did not reach statistical significance (HR, 0.75; 95% CI, 0.55-1.02).”
From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [58]
In the ANDROMEDA-SHOCK study, at day 3 the capillary refill time group had significantly less organ dysfunction as assessed by SOFA score than the lactate group (mean SOFA 5.6 vs 6.6; p = 0.045).
“At day 3, the CRT group had significantly less organ dysfunction as assessed by SOFA score [mean SOFA score 5.6 (SD 4.3) versus 6.6 (SD 4.7); p = 0.045].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [58]
In ANDROMEDA-SHOCK, 28-day mortality was 34.9% in the peripheral perfusion group and 43.4% in the lactate group, but the difference did not reach statistical significance (HR 0.75; 95% CI 0.55-1.02).
“28-day mortality was 34.9% in the peripheral perfusion group and 43.4% in the lactate group, but this difference did not reach statistical significance (HR 0.75; 95% CI 0.55–1.02).”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [58]
Lactate testing may not be readily available in many resource-limited settings.
“Lactate testing may not be readily available in many resource-limited settings [54–61].”
From Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021 (2021) · cites this paper as [58]
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- Authors
- Hernández, G., Ospina-Tascón, G. A., Damiani, L. P., Estenssoro, E., Dubin, A., Hurtado, J., Friedman, G., Castro, R., Alegría, L., Teboul, J.-L., Cecconi, M., Ferri, G., Jibaja, M., Pairumani, R., Fernández, P., Barahona, D., Granda-Luna, V., Cavalcanti, A. B., Bakker, J., & for the ANDROMEDA-SHOCK Investigators and the Latin America Intensive Care Network (LIVEN)
- Affiliations
- Departmento de Medicina Intensiva, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago
- Fundación Valle del Lili (CO)
- Universidade de São Paulo (BR)
- Hospital Interzonal de Agudos San Martín de La Plata, La Plata, Argentina
- Sanatorio Otamendi, Buenos Aires, Argentina
- Universidad de la República de Uruguay (UY)
- Universidade Federal do Rio Grande do Sul (BR)
- Pontificia Universidad Católica de Chile (CL)
- Université Paris-Sud (FR)
- Humanitas University (IT)
- Hospital Barros Luco-Trudeau (CL)
- Universidad Internacional del Ecuador (EC)
- Hospital Regional de Concepción (CL)
- Central University of Ecuador (EC)
- Unidad de Cuidados Intensivos, Hospital San Francisco, Pontificia Universidad Católica de Quito, Quito, Ecuador
- ORCID
- Venue
- JAMA
- Publisher
- American Medical Association (AMA)
- Published
- 2019-02-19
- Volume
- 321
- Issue
- 7
- Pages
- 654
- ISSN
- 0002-9955 (ISSN-L)
- 0098-7484
- PMC
- PMC6439620
- OpenAlex
- W2912774204
- Semantic Scholar
- 88331f7171a26b07b5daabc2215abde544a41780
- Cited by
- 946
- References
- 39
- Citations by year
- 2026: 180 · 2025: 135 · 2024: 122 · 2023: 107 · 2022: 91 · 2021: 102 · 2020: 145 · 2019: 61 · 2015: 1
- FWCI
- 75.59
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- LA Referencia (Red Federada de Repositorios Institucionales de Publicaciones Científicas) (submittedVersion, cc-by-nc-sa)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- HAL (submittedVersion)
- Funders
- Fundación Valle del Lili
- Universidad de Chile
- Topics
- Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
- Health Sciences › Medicine › Surgery › Hemodynamic Monitoring and Therapy
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Abdominal Surgery and Complications
- Keywords
- septic shock, fluid resuscitation, capillary refill time, peripheral perfusion, serum lactate, 28-day mortality, organ dysfunction, SOFA score, vasopressor-free days, renal replacement therapy, mechanical ventilation, ICU length of stay
- MeSH terms
- Aged, Capillaries, Cause of Death, Female, Fluid Therapy, Hemodynamics, Humans, Intensive Care Units, Male, Middle Aged, Respiration, Artificial, Resuscitation, Shock, Septic, Vasoconstrictor Agents, Proportional Hazards Models, Renal Replacement Therapy, Lactic Acid, Kaplan-Meier Estimate, Organ Dysfunction Scores
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