Status:
RECRUITING
Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Intensive Care Unit Acquired Weakness
Shock, Septic
Eligibility:
All Genders
18+ years
Phase:
NA
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 strategi...
Detailed Description
Septic shock is associated with a high mortality risk related to progressive tissue hypoperfusion.However, despite extensive research on the best monitoring and resuscitation strategies, many uncertai...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06062303
Start Date
February 6 2024
End Date
May 30 2026
Last Update
December 5 2024
Active Locations (1)
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1
Hôpital Robert Debré, Université de Reims
Reims, France, 51092