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The proposal.

Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock.

One-size-fits-all resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking.  Hemodynamic phenotyping may allow individualizing septic shock resuscitation.

The ANDROMEDA-SHOCK trial showed that CRT-targeted resuscitation in septic shock reduced organ dysfunction and 28-day mortality. The current study will test the hypothesis that resuscitation based on hemodynamic phenotyping considering pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock.


The ANDROMEDA-2 study is a multicenter, multinational randomized controlled trial which aims to determine if a peripheral perfusion-guided strategy consisting in capillary refill time-targeted resuscitation based on clinical and hemodynamic phenotypes (CRT-P), is associated with a decrease in a composite outcome of mortality, time to cessation of organ support, and length of hospital stay, as compared to usual care (UC) in patients with early (< 4 hours of diagnosis) septic shock.

In the intervention group, CRT will be measured hourly for 6 hours. If abnormal, patients will enter in an algorithm that starts with pulse pressure (PP) assessment. Patients with less than 40 mmHg will be tested for fluid responsiveness and receive fluids accordingly. In patients with PP > 40 mmHg, norepinephrine will be titrated in order to maintain diastolic arterial pressure > 50 mmHg.  Patients that fail to normalize CRT after the previous steps, will be subjected to critical care echocardiography for evaluation and subsequent management of cardiac dysfunction. Finally, vasopressor and inodilator tests will be performed at the end of the algorithm to further optimize perfusion.  A sample size of of 1500 patients will provide a power of 88% to show superiority of the CRT-P strategy over UC.

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