Septic Shock
Conditions
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.
Interventions
PROCEDUREPersonalised fluid and haemodynamic resuscitation
individualised resuscitation
Sponsors
Pontificia Universidad Catolica de Chile
University of Rotterdam, The Netherlands
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| hospital mortality | 28 days | number of patients who died in hospital |
| organ support | 28 days | time to cessation of vital organ support |
| length of stay | 28 days | length of stay in hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 60 days | number of patients who died |
| vital organ support | 28 days | number of days without vital organ support |
| length of stay | 60 days | length of stay in hospital |
Contacts
Primary ContactMarlies Ostermann, PhD
Backup ContactGillian Radcliffe
Outcome results
None listed