Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Not Applicable

Not yet recruiting

• Conditions: Sepsis; Emergency Care; Microcirculation

• Registration Number: NCT06910891
• Lead Sponsor: University Hospital, Limoges

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.

Detailed Description

Sepsis and its most serious form, septic shock, are a public health problem. Sepsis is defined by the presence of organ failure, including acute circulatory failure, which combines hypovolemia, vasoplegia and cardiac dysfunction. Vascular filling is therefore a pillar of the management of septic patients to correct hypovolemia and improve perfusion and tissue oxygenation. Following numerous studies, the evaluation of peripheral microcirculation is becoming a clinical "trigger" making it possible to identify patients at risk, particularly in emergency department. In a meta-analysis, it has been showed that alterations in microcirculatory perfusion predict deterioration and mortality during severe infections. Currently, no interventional study has evaluated the impact of measuring microcirculatory perfusion (peripheral perfusion index and marbling) by nurses on patient prognosis through early initiation of vascular filling.

In this study, patients will be assessed hemodynamically using peripheral perfusion index and/or presence of mottling. If peripheral perfusion index \> 3s and/or presence of marbling a first vascular filling test of 500 cc over 30 minutes will be started after a medical control.

Patient will be followed up 7 days to determine outcome.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-21
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Study Start: 2025-06-01
• Primary Completion: 2026-12-18
• Study Completion: 2026-12-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 556

Inclusion Criteria

1. Age ≥ 18 years
2. 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)
3. Affiliated to a social security system
4. Having agreed to participate in this study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number and proportion of patients presenting clinical deterioration during emergency care	between time of inclusion and 24 hours after	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

Secondary Outcome Measures

Name	Time	Method
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
The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician	hour 0
Number and proportion of patients sent home, conventional hospitalization or intensive care	from enrollment to the end of the subject participation at day 7
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

Trial Locations

Locations (6)

Brive Hospital; 🇫🇷 Brive, France

Guéret Hospital; 🇫🇷 Guéret, France

Limoges University Hospital; 🇫🇷 Limoges, France

Saint Junien Hospital; 🇫🇷 Saint Junien, France

Tulle Hospital; 🇫🇷 Tulle, France

Ussel Hospital; 🇫🇷 Ussel, France