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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00216-43 | Other Identifier | IDRCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
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| Control arm | No Intervention | Patients will benefit from treatment according to current standards of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| measurement of the peripheral perfusion index and marbling assessment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of patients presenting clinical deterioration during emergency care | Clinical deterioration is defined by (composite criterion):
| between time of inclusion and 24 hours after |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Difference in SOFA score (≥ 2 points) between Hours 0 and Hours 24 (24h±6h) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anaelle NARDOT-SUCHAUD | Contact | 0519761835 | Anaelle.NARDOT-SUCHAUD@chu-limoges.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brive Hospital | Recruiting | Brivé | 19100 | France |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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Quasi-experimental interventional study of the here-elsewhere type, open and multicenter
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| 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 |
| 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 |
| Guéret Hospital | Recruiting | Guéret | 23000 | France |
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| Limoges University Hospital | Recruiting | Limoges | 87000 | France |
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| Saint Junien Hospital | Recruiting | Saint-Junien | 87200 | France |
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| Tulle Hospital | Recruiting | Tulle | 19012 | France |
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| Ussel Hospital | Recruiting | Ussel | 19200 | France |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |