Personalized Hemodynamic and Capillary Refill Time-Guided Resuscitation for Adults With Early Septic Shock in the ANDROMEDA-SHOCK-2 Trial

What this Trial Is About

Researchers are evaluating a new approach to resuscitation in adults with early septic shock, a serious condition where the bodys response to infection causes dangerously low blood pressure and organ failure. The study aims to compare a personalized resuscitation strategy based on hemodynamic phenotyping and capillary refill time CRT targeting, with usual care. This approach considers bedside clinical parameters like pulse pressure, diastolic blood pressure, fluid responsiveness, and cardiac function to reduce mortality and organ dysfunction compared to standard methods that often apply a one-size-fits-all treatment. Participants will be randomly assigned to either the usual care group, managed according to general clinical guidelines including use of norepinephrine and fluid administration, or to the CRT-targeted phenotyping group. In this group, treatment decisions follow a decision tree assessing CRT, pulse pressure, fluid responsiveness, diastolic arterial pressure, and cardiac ultrasound when needed. Fluid boluses and norepinephrine doses are adjusted based on these measures, aiming to avoid fluid overload and optimize blood flow. Patients with normal CRT are periodically monitored, while those with abnormal CRT receive tailored interventions and further assessments. During the 28-day study period, participants will be closely monitored for outcomes including mortality, duration of vital support, and length of hospital stay. Researchers will evaluate all-cause 28-day mortality combined with time until stopping vital support and hospital discharge. Continuous clinical assessments, hemodynamic monitoring, and organ function evaluations will guide treatment adjustments. Safety and effectiveness of this individualized resuscitation approach will be compared to usual care, with follow-up extending through the hospital stay and 28 days after treatment begins.

Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2