UK ANDROMEDA-Shock-2 RCT

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Apr 10, 2024

Keywords

ClinConnect Summary

The UK ANDROMEDA-Shock-2 trial is studying a new way to treat patients with septic shock, a serious condition caused by severe infections. Researchers want to find out if a special approach that monitors how quickly blood returns to the capillaries (tiny blood vessels) can help improve recovery within 28 days, compared to standard treatment. This trial is not yet recruiting participants, but it aims to include adults aged 18 and older who meet specific criteria for septic shock.

To be eligible for the trial, participants must have been diagnosed with septic shock and show certain signs, such as needing medication to support blood pressure after receiving a specific amount of fluids. However, some people may not be able to join, including those who have had septic shock for more than four hours, are scheduled for surgery soon, or have certain serious health issues. If someone is eligible and chooses to participate, they will be closely monitored and receive treatment according to the new strategy being tested. This trial could lead to better outcomes for patients with this challenging condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Consecutive adult patients (≥ 18 years) with septic shock defined by Sepsis-3 consensus criteria. (ie septic shock defined as suspected or confirmed infection, hyperlactatemia and noradrenaline requirement, after a fluid load of at least 1000mL in 1 hour)
• Exclusion Criteria:
• Any of the following criteria preclude participation to the trial:
• • 1. More than 4 hours since septic shock diagnosis,
• • 2. Surgery or acute renal replacement therapy anticipated to start during the 6h intervention period
• • 3. Active bleeding,
• • 4. Child B-C Cirrhosis
• • 5. Underlying disease process with a life expectancy \<90 days
• • 6. Attending clinician deems aggressive resuscitation unsuitable
• • 7. Refractory shock (high risk of death within 24h)
• • 8. Pregnancy
• • 9. Concomitant severe acute respiratory distress syndrome
• • 10. Capillary refill time cannot be accurately assessed