Clinical trial NCT06366854: UK ANDROMEDA-Shock-2 RCT
Official title: Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The UK ANDROMEDA-SHOCK-2 Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Septic Shock
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica de Chile
name: University of Rotterdam, The Netherlands
First posted: 2024-04-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to test if a strategy of resuscitation guided by capillary refill time and individualised clinical hemodynamic phenotyping can improve important clinical outcomes within 28 days in septic shock patients compared to usual care.

Detailed description: 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 RCT 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, the investigators will also take a total of 40ml of blood and 60ml of urine for special kidney tests to evaluate kidney health and recovery of kidney function.

After the study has finished, the investigators 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.

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

Primary outcomes:
measure: hospital mortality
timeFrame: 28 days
measure: organ support
timeFrame: 28 days
measure: length of stay
timeFrame: 28 days
Secondary outcomes:
measure: mortality
timeFrame: 60 days
measure: vital organ support
timeFrame: 28 days
measure: length of stay
timeFrame: 60 days
Other outcomes:
Locations:
Study officials:
References: