Targeted resuscitation approach for septic shock patients
Official title: Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)
Run by Assistance Publique - Hôpitaux de Paris · NCT06062303 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Reims) |
| Status | Recruiting |
| Started | February 6, 2024 |
| Main results expected | December 1, 2025 |
| Study ends | May 30, 2026 |
| Registry record updated | December 5, 2024 |
| Trial ID | NCT06062303 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies, such as the ANDROMEDA-SHOCK trial, have shown success with similar targeted resuscitation approaches, indicating potential for this methodology.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Hôpital Robert Debré, Université de Reims
Reims, France Recruiting
Study contacts
- Study coordinator: Olfa MD Hamzaoui, PhD
- Email: ohamzaoui@chu-reims.fr
- Phone: 0033310736973
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Blood flow restriction training for ICU patients on ventilators with ICU-acquired weakness
This study tests whether a low-load blood flow restriction exercise program can help restore muscle strength in adults with ICU-acquired weakness who are on invasive mechanical ventilation.
-
Tracking changes in physical strength for adults in the ICU
We will test whether changes in the Chelsea Critical Care Physical Assessment Tool (CPAx) score between ICU admission and discharge can predict outcomes like death and how long adults need mechanical ventilation.
-
VR-based rehabilitation in the ICU for improved patient satisfaction and function
This trial tests immersive virtual reality rehab in ICU patients to see if it improves satisfaction and functional outcomes.
-
Early check of quadriceps strength in ICU patients on invasive ventilation
This study tests whether early measurement of quadriceps strength using dynamometry and 3D ultrasound can help track recovery in adults in the ICU who are on invasive mechanical ventilation.
-
Identifying Photoplethysmographic Waves in Adults with Septic Shock
This study is trying to see what different types of blood flow signals look like in adults with septic shock and how they relate to signs of poor blood circulation.
-
Technology-assisted early mobilization for ICU patients on ventilators
This trial will test whether a technology-assisted, family-engaged early mobilization program helps critically ill adults on ventilators avoid ICU-acquired weakness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.