UK ANDROMEDA-Shock-2 RCT

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: Personalised fluid and haemodynamic resuscitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marlies Ostermann, PhD; Phone Number: 00442071883036; Email: Marlies.Ostermann@gstt.nhs.uk
• Study Contact Backup: Name: Gillian Radcliffe; Phone Number: 00442071883036; Email: Gillian.Radcliffe@gstt.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: Personalised fluid and haemodynamic resuscitation; individualised resuscitation
Active Comparator: control group; Management guided by clinical team	Procedure: Personalised fluid and haemodynamic resuscitation; individualised resuscitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital mortality	number of patients who died in hospital	28 days
organ support	time to cessation of vital organ support	28 days
length of stay	length of stay in hospital	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	number of patients who died	60 days
vital organ support	number of days without vital organ support	28 days
length of stay	length of stay in hospital	60 days

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: Pontificia Universidad Catolica de Chile; University of Rotterdam, The Netherlands

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 10, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: IRAS: 332418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No