Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Limoges
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
measurement of the peripheral perfusion index and marbling assessment
Diagnostic testin 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
Treatment groups
556 Participants
are divided into 2 treatment groupsGroup A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
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
Time frame
between time of inclusion and 24 hours afterSecondary outcomes
1
Number and proportion of patients who received bundles (i) one hour and (ii) 3 hours of admission to the Emergency Department
Time frame
from admission to the Emergency Department to 3 hours after2
Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h)
Time frame
between Hours 0 and Hours 243
Number and proportion of deaths on Day 7
Time frame
from enrollement to the end of the patient participation at Day 74
Number and proportion of patients with hydrostatic pulmonary oedema (cardiogenic or volume overload) or receiving diuretic treatment during emergency care
Time frame
from enrollment to the end of the subject participation at day 7Sponsors and contacts
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Source ClinicalTrials.gov