Actively Recruiting
Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-05
180
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to resuscitation in adults with early septic shock, a serious condition where the body's response to infection causes dangerously low blood pressure and organ failure. The study aims to compare a personalized resuscitation strategy based on hemodynamic phenotyping and capillary refill time (CRT) targeting, with usual care. This approach considers bedside clinical parameters like pulse pressure, diastolic blood pressure, fluid responsiveness, and cardiac function to reduce mortality and organ dysfunction compared to standard methods that often apply a one-size-fits-all treatment. Participants will be randomly assigned to either the usual care group, managed according to general clinical guidelines including use of norepinephrine and fluid administration, or to the CRT-targeted phenotyping group. In this group, treatment decisions follow a decision tree assessing CRT, pulse pressure, fluid responsiveness, diastolic arterial pressure, and cardiac ultrasound when needed. Fluid boluses and norepinephrine doses are adjusted based on these measures, aiming to avoid fluid overload and optimize blood flow. Patients with normal CRT are periodically monitored, while those with abnormal CRT receive tailored interventions and further assessments. During the 28-day study period, participants will be closely monitored for outcomes including mortality, duration of vital support, and length of hospital stay. Researchers will evaluate all-cause 28-day mortality combined with time until stopping vital support and hospital discharge. Continuous clinical assessments, hemodynamic monitoring, and organ function evaluations will guide treatment adjustments. Safety and effectiveness of this individualized resuscitation approach will be compared to usual care, with follow-up extending through the hospital stay and 28 days after treatment begins.
CONDITIONS
Brief Title
Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Diagnosis of septic shock according to Sepsis-3 criteria, including suspected or confirmed infection, elevated lactate, and norepinephrine requirement after fluid resuscitation
- Informed consent provided by patient or relative
You will not qualify if you...
- More than 4 hours since septic shock diagnosis
- Planned surgery or acute hemodialysis during the 6-hour intervention
- Active bleeding
- Do not resuscitate status
- Child B-C cirrhosis
- Life expectancy less than 90 days or deemed unsuitable for aggressive resuscitation
- Refractory shock with high risk of death within 24 hours
- Pregnancy
- Severe acute respiratory distress syndrome
- Inability to accurately assess capillary refill time
- Not affiliated with social security or equivalent
- Under state medical aid without exemption
- Under legal protection (guardianship or curatorship)
- Participation in another interventional study or within exclusion period
- Inability to understand the study due to language or cognitive issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 hours
Participants receive hemodynamic phenotype-based resuscitation strategies or usual care to manage early septic shock, including fluid boluses, norepinephrine adjustments, and monitoring of capillary refill time and cardiovascular function.
Continuous monitoring during the intervention period
Duration - 28 days
Participants are monitored for outcomes including survival, vital support needs, and hospital stay length up to 28 days after treatment.
Periodic assessments during hospital stay up to 28 days
Trial Site Locations
Total: 1 location
1
Hôpital Robert Debré, Université de Reims
Reims, France, 51092
Actively Recruiting
Research Team
O
Olfa MD Hamzaoui, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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