UK ANDROMEDA - SHOCK-2

  • Research type

    Research Study

  • Full title

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

  • IRAS ID

    332418

  • Contact name

    Marlies Ostermann

  • Contact email

    Marlies.Ostermann@gstt.nhs.uk

  • Sponsor organisation

    Guy's & St Thomas' NHS Foundation Hospital

  • Clinicaltrials.gov Identifier

    NCT06366854

  • Duration of Study in the UK

    3 years, 0 months, 1 days

  • Research summary

    Septic shock is a life-threatening condition caused by a severe infection. It can rapidly cause multi-organ failure and is associated with a high risk of dying. Patients with septic shock need emergency treatment with intravenous fluids, antibiotics and medications to improve blood supply to all organs. However, it is clear that giving too much fluid is harmful and giving not enough fluid can make organ failure worse, too. International guidelines exist but there is still a lot of variation in how doctors apply the guideline. Further, it is likely that a "one-size-fits-all" approach does not help all patients.
    Previously, the Andromeda-Shock 1 trial showed that resuscitation guided by regular monitoring of skin perfusion was associated with a lower risk of dying than resuscitation guided by regular blood tests. The UK Andromeda-Shock 2 trial builds on this. The aim is to investigate whether an individualised approach based on monitoring of skin perfusion combined with individualised treatment of the blood pressure and circulation for 6 hours is better for patients with septic shock and reduces the risk of organ failure and dying compared to usual care.
    During the study period, we will also take a total of 60ml of blood and 90ml of urine for special kidney tests to evaluate kidney health and recovery of kidney function.
    After the study has finished, we plan to share fully anonymised results with the investigators of the international Andromeda Shock 2 trial to get as much information as possible to answer the research question and help patients in future.

  • REC name

    London - Camberwell St Giles Research Ethics Committee

  • REC reference

    24/LO/0377

  • Date of REC Opinion

    10 Jun 2024

  • REC opinion

    Further Information Favourable Opinion