Actively Recruiting
Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
Led by University Hospital, Limoges · Updated on 2025-11-21
556
Participants Needed
6
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Sepsis and its severe form, septic shock, are serious health concerns characterized by organ failure and acute circulatory problems like low blood volume, blood vessel dilation, and heart dysfunction. Researchers are evaluating whether measuring microcirculation parameters such as the peripheral perfusion index and skin marbling by nurses can improve early treatment decisions and patient outcomes. This study focuses on the early detection of tissue blood flow problems that may not be obvious through standard measurements and aims to assess if early vascular filling based on these measures can reduce deterioration and mortality. Participants will be monitored using classic hemodynamic parameters plus additional measurements of peripheral perfusion index and marbling score. If the peripheral perfusion index is 3 seconds or more or marbling is present at a score of 1 or higher, nurses will initiate a vascular filling test by administering 500 cc of fluid over 30 minutes after confirmation by a senior doctor. All patients will continue to receive standard care treatments. This intervention period is closely linked to emergency department admission. Throughout the study, patients will be followed for 7 days to track clinical outcomes including deterioration within 24 hours after inclusion, organ function changes, mortality, lung fluid overload, and care setting decisions such as discharge or intensive care admission. The study also compares nurse and physician assessments of microcirculation. This detailed monitoring includes timing of treatment bundles and safety checks to evaluate how early microcirculation measurement impacts sepsis management and patient prognosis.
CONDITIONS
Brief Title
Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Admitted to the Emergency Department for suspected sepsis within less than 6 hours according to Sepsis-3 definitions
- High probability of infection with fever ≥ 38.3°C and NEWS 2 score ≥ 2
- Affiliated to a social security system
- Agreed to participate in this study
You will not qualify if you...
- Arterial hypotension (systolic blood pressure ≤ 100 mmHg) on admission
- Already received a 500 mL fluid filling test over 30 minutes
- Considered moribund by the investigator
- Pregnancy or breastfeeding
- Under guardianship, curatorship, or safeguard of justice
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 hours before enrollment
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 minutes for vascular filling; treatment and assessments occur during emergency care
Participants identified with altered peripheral perfusion index or marbling will receive a vascular filling test of 500 cc over 30 minutes. Participants in the control group receive standard care according to current practices.
1 treatment period during emergency care
Duration - 7 days
Participants are followed for 7 days after treatment to assess clinical outcomes and any complications.
Daily assessments for up to 7 days
Trial Site Locations
Total: 6 locations
1
Brive Hospital
Brivé, France, 19100
Actively Recruiting
2
Guéret Hospital
Guéret, France, 23000
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3
Limoges University Hospital
Limoges, France, 87000
Actively Recruiting
4
Saint Junien Hospital
Saint-Junien, France, 87200
Actively Recruiting
5
Tulle Hospital
Tulle, France, 19012
Actively Recruiting
6
Ussel Hospital
Ussel, France, 19200
Actively Recruiting
Research Team
A
Anaelle NARDOT-SUCHAUD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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