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This study aims to assess the effect of acute inflammation on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls.
The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).
In a model of acute inflammation induced by salmonella typhi vaccination in healthy volunteers, it has been shown that acute systemic inflammation increased arterial stiffness. Since increased arterial stiffness (assessed by carotid-femoral pulse wave velocity) is an independent prognosis marker of cardiovascular risk in many chronic diseases such as hypertension, renal failure or diabetes mellitus, it could also be a marker of severity in acute inflammation states. Severe sepsis is a leading cause of hospitalisation in intensive care units, and constitutes a state of acute inflammation. It remains however to confirm that arterial stiffness is increased in this clinical conditions before evaluating its prognosis value.
This study aims to assess the effect of severe sepsis on arterial stiffness and microcirculation. Patients with severe sepsis will be compared with age-, sex- and cardiovascular risk factors-matched controls.
The primary outcome is the carotid-femoral pulse wave velocity. The other outcome measures are: systemic hemodynamics (systolic, diastolic, mean and pulse blood pressures, heart rate, cardiac output, left ventricular ejection fraction, systemic vascular resistances), central hemodynamics (aortic systolic, diastolic, mean and pulse pressures, and augmentation index), thenar tissue oxygen saturation, biological makers of inflammation (plasma fibrinogen, C-reactive protein, interleukin-6, matrix metalloproteinases -2, -9, tissue inhibitor of metalloproteinase 1), and plasma catecholamine concentrations (epinephrine, norepinephrine).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| severe sepsis | patients with severe sepsis |
| |
| Controls | Controls matched to patients on age, sex and cardiovascular risk factors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA : non interventional study | Other | NA : non interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Carotid-femoral pulse wave velocity | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Systemic hemodynamics |
| 1 day |
| Central aortic hemodynamic |
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Inclusion Criteria:
Control group :
Patients group :
Male or female aged at least 18 years
Severe sepsis defined by the presence of:
Body mass index between 18 and 27 Kg/m²
Written informed consent from the patients or their relatives
Exclusion Criteria:
Control group :
Patients group :
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20 patients with severe sepsis. 20 controls matched on age, sex and cardiovascular risk factors .
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| Name | Affiliation | Role |
|---|---|---|
| Bruno LAVIOLLE, MD, PhD | Rennes University Hospital | Principal Investigator |
| Eric BELLISSANT, MD, PhD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Chirurgicale - Hôpital de Pontchaillou | Rennes | 35033 | France | |||
| Unité d'Investigation Clinique - Hôpital de Pontchaillou |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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serum
| 1 day |
| Micro-circulation | Thenar tissue oxygen saturation | 1 day |
| Biological markers from plasma samples |
| 1 day |
| Rennes |
| 35033 |
| France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |