RecruitingNot ApplicableNCT06062303

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)

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

180 participants

Start Date

Feb 6, 2024

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Inclusion Criteria3

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 Criteria15

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)

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Interventions

OTHERUsual 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

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NCT06062303