Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06910891

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

On this page

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - Up to 6 hours before enrollment

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

Actively Recruiting

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

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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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