NCT06062303 Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2
| NCT ID | NCT06062303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Intensive Care Unit Acquired Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2025-12-01 |
Trial Parameters
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Brief Summary
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 to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.
Eligibility Criteria
Inclusion Criteria: * Consecutive adult patients (≥ 18 years) * Patients with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h * Patient and/or relative informed and having signed the information and consent form for participation in the study Exclusion Criteria: * More than 4 hours since septic shock diagnosis, * Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period * Active bleeding, * Do not resuscitate status, * Child B-C Cirrhosis * Underlying disease process with a life expectancy \< 90 days and/or the attending clinician deems aggressive resuscitation unsuitable * Refractory shock (high risk of death within 24h) * Pregnancy * Concomitant severe acute respiratory distress syndrome * Patients in whom CRT cannot be accurately assessed * Non-affiliati