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
1 other identifier
interventional
25
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2024
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 16, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
June 20, 2024
June 1, 2024
2.8 years
April 2, 2024
June 18, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
mortality
60 days
vital organ support
28 days
length of stay
60 days
Study Arms (2)
Intervention
ACTIVE COMPARATORManagement 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.
control group
ACTIVE COMPARATORManagement guided by clinical team
Interventions
individualised resuscitation
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Any of the following criteria preclude participation to the trial:
- More than 4 hours since septic shock diagnosis,
- Surgery or acute renal replacement therapy anticipated to start during the 6h intervention period
- Active bleeding,
- Child B-C Cirrhosis
- Underlying disease process with a life expectancy \<90 days
- Attending clinician deems aggressive resuscitation unsuitable
- Refractory shock (high risk of death within 24h)
- Pregnancy
- Concomitant severe acute respiratory distress syndrome
- Capillary refill time cannot be accurately assessed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 16, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
June 20, 2024
Record last verified: 2024-06