Hemodynamic Evaluation Using Microcirculation for Early Treatment of Septic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: measurement of the peripheral perfusion index and marbling assessment.
- Who it may be relevant to
- Registry conditions: Sepsis, Emergency Care, Microcirculation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- Number and proportion of patients presenting clinical deterioration during emergency care [Time frame: between time of inclusion and 24 hours after]
Secondary outcome measures (6)
- 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 after]
- Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h) [Time frame: between Hours 0 and Hours 24]
- Number and proportion of deaths on Day 7 [Time frame: 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 [Time frame: 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 [Time frame: hour 0]
- Number and proportion of patients sent home, conventional hospitalization or intensive care [Time frame: from enrollment to the end of the subject participation at day 7]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 6 centers
- Brive Hospital — Brivé
- Guéret Hospital — Guéret
- Limoges University Hospital — Limoges
- Saint Junien Hospital — Saint-Junien
- Tulle Hospital — Tulle
- Ussel Hospital — Ussel
Identifiers
NCT: NCT06910891 · 87RI24_0047 (HEMOCAP · 2025-A00216-43