UK ANDROMEDA-Shock-2 RCT

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06366854
• Other study ID #: IRAS: 332418
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 30, 2028

Study information

• Verified date: June 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Marlies Ostermann, PhD
• Phone: 00442071883036
• Email: Marlies.Ostermann[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: April 30, 2028
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Procedure:
• Personalised fluid and haemodynamic resuscitation
individualised resuscitation

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	Pontificia Universidad Catolica de Chile, University of Rotterdam, The Netherlands

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital mortality	number of patients who died in hospital	28 days
Primary	organ support	time to cessation of vital organ support	28 days
Primary	length of stay	length of stay in hospital	28 days
Secondary	mortality	number of patients who died	60 days
Secondary	vital organ support	number of days without vital organ support	28 days
Secondary	length of stay	length of stay in hospital	60 days