Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

NCT06910891 | Recruiting

• 2 other identifiers: 87RI24_0047 (HEMOCAP2025-A00216-43
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 6

Brief Summary

Despite early treatment, the deterioration and mortality of sepsis patients remains high. A possible explanation could be persistent tissue hypoperfusion, or undetected in the early phase despite the normalization of macro-hemodynamic parameters. This interventional study evaluates the impact of measuring microcirculation parameters by nurses on patient prognosis through early initiation of vascular filling.

Conditions

Sepsis; Emergency Care; Microcirculation

Keywords

microcirculation; septic patient; organ dysfunction; sepsis; peripheral perfusion index; emergency unit

Outcome Measures

Primary Outcomes (1)

• Number and proportion of patients presenting clinical deterioration during emergency care

  Clinical deterioration is defined by (composite criterion): 1. Arterial hypotension defined by systolic blood pressure (SBP) ≤ 100 mmHg 2. Implementation of treatment for organ support: * Vasopressor or inotrope * Invasive ventilation 3. Abnormal lactate concentration (\> 2mmol/L), without improvement (absence of decay) 4. Patient admitted in intensive care unit 5. Death

  between time of inclusion and 24 hours after

Secondary Outcomes (6)

• Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department

  from admission to the Emergency Department to 3 hours after

• Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)

  between Hours 0 and Hours 24

• Number and proportion of deaths on Day 7

  from enrollement to the end of the patient participation at Day 7

• Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care

  from enrollment to the end of the subject participation at day 7

• The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician

  hour 0

Study Arms (2)

Intervention arm

EXPERIMENTAL

As soon as an eligible patient is identified by the nurse, in addition to the classic hemodynamic parameters measured in all patients, a measurement of the peripheral perfusion index (from 1 sec to 10 sec) and marbling assessment (scale from 0 to 5) will be performed. This measurement will be validated by the senior doctor of the Sepsis Department. When the peripheral perfusion index will be ≥ 3 sec and/or the marbling score ≥ 1, a first vascular filling test of 500 cc over 30 minutes will be started, regardless of the value of the hemodynamic parameters.

Diagnostic Test: measurement of the peripheral perfusion index and marbling assessment

Control arm

NO INTERVENTION

Patients will benefit from treatment according to current standards of care

Interventions

measurement of the peripheral perfusion index and marbling assessment DIAGNOSTIC_TEST

in addition to the classic hemodynamic parameters measured in all patients, a measurement of the peripheral perfusion index (from 1 sec to 10 sec) and marbling assessment (scale from 0 to 5) will be performed

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Admitted to the Emergency Department for suspected Sepsis for less than 6 hours according to international Sepsis-3 definitions (high probability of infection defined by a fever greater than or equal tol to 38.3°C with a suspected infectious source + Score NEWS 2 greater than or equal to 2)
• Affiliated to a social security system
• Having agreed to participate in this study

You may not qualify if:

• Patient with arterial hypotension (SBP ≤ 100 mmHg) on admission
• Patient having already received a 500mL filling test over 30 minutes
• Patients moribund according to the investigator
• Pregnancy or breastfeeding
• Patient under guardianship, curatorship or safeguard of justice

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (6)

Brive Hospital

Brivé, 19100, France

RECRUITING

Guéret Hospital

Guéret, 23000, France

RECRUITING

Limoges University Hospital

Limoges, 87000, France

RECRUITING

Saint Junien Hospital

Saint-Junien, 87200, France

RECRUITING

Tulle Hospital

Tulle, 19012, France

RECRUITING

Ussel Hospital

Ussel, 19200, France

RECRUITING

MeSH Terms

Conditions

Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Central Study Contacts

Anaelle NARDOT-SUCHAUD

CONTACT

0519761835; Anaelle.NARDOT-SUCHAUD@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental interventional study of the here-elsewhere type, open and multicenter

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 4, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): March 28, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

FR (6)