RECRUITINGINTERVENTIONAL

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

Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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-affiliation to a social security scheme or to another social protection scheme - Patient on AME (state medical aid) (unless exemption from affiliation - Patient under legal protection (guardianship, curatorship) - Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable - Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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-affiliation to a social security scheme or to another social protection scheme * Patient on AME (state medical aid) (unless exemption from affiliation * Patient under legal protection (guardianship, curatorship) * Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable * Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders)

Treatments Being Tested

OTHER

Usual care (UC)

\- Patients allocated to the UC group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP \>65 mmHg, heart rate (HR) \<120 beats per minute (BPM), arterial oxygen saturation (SaO2) \>94%, Hb \> 7 gr/dl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.

Locations (1)

Hôpital Robert Debré, Université de Reims

Reims, France