UK ANDROMEDA-Shock-2 RCT

NCT ID: NCT06366854

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-04-30

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.

Conditions

Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Management consists of a strategy that targets capillary refill time and individualised haemodynamic parameters, using vasopressors, fluids as guided by fluid responsiveness tests and inotropic support as guided by echocardiography.

Group Type: ACTIVE_COMPARATOR

Personalised fluid and haemodynamic resuscitation

Intervention Type: PROCEDURE

individualised resuscitation

control group

Management guided by clinical team

Group Type: ACTIVE_COMPARATOR

Personalised fluid and haemodynamic resuscitation

Intervention Type: PROCEDURE

individualised resuscitation

Interventions

Personalised fluid and haemodynamic resuscitation

individualised resuscitation

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: collaborator

University of Rotterdam, The Netherlands

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Marlies Ostermann, PhD

Role: CONTACT

Marlies.Ostermann@gstt.nhs.uk

00442071883036

Gillian Radcliffe

Role: CONTACT

Gillian.Radcliffe@gstt.nhs.uk

00442071883036

Other Identifiers

IRAS: 332418

Identifier Type: -

Identifier Source: org_study_id