NCT06062303 Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2
| NCT ID | NCT06062303 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Intensive Care Unit Acquired Weakness |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-02-06 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06062303 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intensive Care Unit Acquired Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06062303 currently recruiting?
Yes, NCT06062303 is actively recruiting participants. Contact the research team at ohamzaoui@chu-reims.fr for enrollment information.
Where is the NCT06062303 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06062303 clinical trial?
NCT06062303 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 180 participants.