Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

556 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-20

Study Completion Date

2027-03-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Emergency Care Microcirculation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention arm

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.

Group Type EXPERIMENTAL

measurement of the peripheral perfusion index and marbling assessment

Intervention Type 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

Control arm

Patients will benefit from treatment according to current standards of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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measurement of the peripheral perfusion index and marbling assessment

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 Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No