Clinical trial NCT06910891: Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
Official title: Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sepsis
Emergency Care
Microcirculation
Keywords: microcirculation
septic patient
organ dysfunction
sepsis
peripheral perfusion index
emergency unit
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental interventional study of the here-elsewhere type, open and multicenter
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and proportion of patients presenting clinical deterioration during emergency care
timeFrame: between time of inclusion and 24 hours after
Secondary outcomes:
measure: Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department
timeFrame: from admission to the Emergency Department to 3 hours after
measure: Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)
timeFrame: between Hours 0 and Hours 24
measure: Number and proportion of deaths on Day 7
timeFrame: from enrollement to the end of the patient participation at Day 7
measure: Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care
timeFrame: from enrollment to the end of the subject participation at day 7
measure: The correlation of the peripheral perfusion index measurement (pathological : yes/no) between the nurse and the emergency physician
timeFrame: hour 0
measure: Number and proportion of patients sent home, conventional hospitalization or intensive care
timeFrame: from enrollment to the end of the subject participation at day 7
Other outcomes:
Locations:
city: Brive
country: France
facility: Brive Hospital
city: Guéret
country: France
facility: Guéret Hospital
city: Limoges
country: France
facility: Limoges University Hospital
city: Saint Junien
country: France
facility: Saint Junien Hospital
city: Tulle
country: France
facility: Tulle Hospital
city: Ussel
country: France
facility: Ussel Hospital
Study officials:
References: