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The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shock + Treatment | Experimental | Patients treated with activated protein C |
|
| Shock | Other | Patients not treated with activated protein C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Activated Protein C | Drug | 24 μg/kg/h during 96 hours - intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular reactivity measured with dose-response to phenylephrine | baseline | |
| Vascular reactivity measured with dose-response to phenylephrine | 4 hours | |
| Vascular reactivity measured with dose-response to phenylephrine | 24 hours |
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Inclusion Criteria:
- Patients with septic shock as determined by standard criteria (including infection and severe infection)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno LEVY | Réanimation Médicale - Hôpital de Brabois - CHRU Nancy | Principal Investigator |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| C000591161 | 3K3A-APC protein |
| C421124 | drotrecogin alfa activated |
| D019265 | Spectroscopy, Near-Infrared |
| D010656 | Phenylephrine |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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| Near-infrared spectroscopy (NIRS) | Device | After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function. |
|
| Phenylephrine | Drug | Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test. |
|
| Blood sample | Biological | Analysis of inflammation and cellular adhesion markers and free radicals |
|
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |