Targeted resuscitation approach for septic shock patients

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

This study tests a personalized treatment plan for people with septic shock to see if using specific signs like capillary refill time can help them recover better than standard methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (Academic / other)
• Locations: 1 site (Reims)
• Trial ID: NCT06062303 on ClinicalTrials.gov

What this trial studies

This study investigates a personalized resuscitation strategy for patients experiencing septic shock by utilizing hemodynamic phenotyping and capillary refill time (CRT) as key indicators. The approach aims to tailor fluid and medication administration based on individual patient responses rather than applying a standard treatment protocol. By analyzing various clinical parameters, the study seeks to reduce organ dysfunction and mortality rates associated with septic shock. The methodology builds on previous findings from the ANDROMEDA-SHOCK trial, which indicated that CRT-targeted resuscitation could improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are adult patients (18 years and older) diagnosed with septic shock as defined by the Sepsis-3 criteria.

Not a fit: Patients who may not benefit include those with a do-not-resuscitate status, severe underlying conditions with a life expectancy of less than 90 days, or those who cannot have CRT accurately assessed.

Why it matters

Potential benefit: If successful, this approach could significantly lower mortality rates and improve recovery times for patients suffering from septic shock.

How similar studies have performed: Previous studies, such as the ANDROMEDA-SHOCK trial, have shown success with similar targeted resuscitation approaches, indicating potential for this methodology.

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-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)

Where this trial is running

Reims

• Hôpital Robert Debré, Université de Reims — Reims, France (Recruiting)

Study contacts

• Study coordinator: Olfa MD Hamzaoui, PhD

Conditions Intensive Care Unit Acquired Weakness; Shock, Septic