Personalized Hemodynamic Resuscitation Targeting Capillary Refill Time in Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial.
Summary
In a 19-country multicenter RCT of early septic shock, a CRT-targeted personalized hemodynamic protocol achieved a significant win ratio (1.16) over usual care on a 28-day hierarchical composite outcome. The benefit was driven mainly by fewer days requiring vasoactive support, mechanical ventilation, and kidney replacement therapy.
Key Findings
- Win ratio of 1.16 (95% CI 1.02–1.33; P=0.04) favoring CRT-personalized resuscitation for the 28-day hierarchical composite.
- Primary benefit components: reduced duration of vital support (vasoactives, mechanical ventilation, kidney replacement therapy).
- Trial spanned 86 centers in 19 countries; stratification by APACHE II supported robustness across illness severity.
Clinical Implications
Adopting CRT-guided personalized resuscitation may reduce exposure to vasoactives, ventilation, and kidney support in early septic shock. Implementation requires protocolized assessment of pulse pressure, diastolic pressure, fluid responsiveness, and point-of-care echocardiography.
Why It Matters
This trial provides high-level evidence that a simple bedside perfusion target (CRT) embedded in a personalized protocol can improve clinically meaningful composite outcomes in septic shock.
Limitations
- Open-label pragmatic design with potential variability in usual care across centers.
- Effect largely on support duration; individual mortality differences were not the main driver.
Future Directions
Evaluate mortality-focused endpoints, cost-effectiveness, and integration with other perfusion/echocardiographic targets; assess implementation fidelity and training needs.
Study Information
- Study Type
- RCT
- Research Domain
- Treatment
- Evidence Level
- I - Randomized, multicenter clinical trial providing highest level evidence for intervention effectiveness.
- Study Design
- OTHER