Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Sep 25, 2023

Keywords

ClinConnect Summary

The ANDROMEDA-SHOCK-2 trial is investigating a new way to treat patients with septic shock, a serious condition caused by severe infections leading to dangerously low blood pressure. The study aims to see if a personalized approach, which tailors treatment based on specific signs from the patient, can improve outcomes compared to standard care. Researchers will focus on a simple measurement called capillary refill time (CRT) and other key indicators to guide resuscitation efforts. This personalized method could potentially reduce the risk of organ failure and help patients recover better.

To participate in this trial, patients must be adults diagnosed with septic shock, meaning they have a suspected or confirmed infection and are experiencing low blood pressure even after receiving a significant amount of fluids. Some patients, such as those with certain serious conditions or those who cannot provide consent, will not be eligible. If chosen to take part, patients can expect close monitoring and individualized treatment strategies aimed at improving their recovery during a critical time in the intensive care unit. This trial is currently recruiting participants of all genders, ages 18 and older.

Gender

ALL

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)