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| Name | Class |
|---|---|
| Azienda Ospedaliero, Universitaria Ospedali Riuniti | OTHER |
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Objective: to test the hypothesis that recombinant activated protein C (aPC) therapy improves the microcirculation of severe septic patients.
Design: Prospective, open study. Setting: University 12-beds intensive care unit. Patients: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis were included in a one year period.
Interventions: Patients who had no contraindication to aPC administration received aPC at a dose of 24 mcg/kg/h for 96 hours. Patients with contraindications to aPC infusion were considered as controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aPC treatment group | Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis treated with activated protein C at 24 mcg/Kg/h for 96 hours | ||
| Control group | Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis not treated with activated protein C because of contraindications |
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| Measure | Description | Time Frame |
|---|---|---|
| Microcirculatory Flow Index (MFI) before during and after aPC infusion | Microcirculatory Flow Index detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quality of blood flow at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve MFI. | 102 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Perfused Vessel Density before during and after aPC infusion | Perfused Vessel Density (PVD) detected in vivo by side-dark field imaging at sublingual microcirculation. It represents the quantity of well perfused vessels at microcirculatory level. This study wants to verify any of the considered different types of blood transfused can improve PVD. | 102 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University ICU, AOU Ospedali Riuniti Ancona | Torrette Di Ancona | Ancona | 60126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24070065 | Result | Donati A, Damiani E, Botticelli L, Adrario E, Lombrano MR, Domizi R, Marini B, Van Teeffelen JW, Carletti P, Girardis M, Pelaia P, Ince C. The aPC treatment improves microcirculation in severe sepsis/septic shock syndrome. BMC Anesthesiol. 2013 Sep 26;13(1):25. doi: 10.1186/1471-2253-13-25. |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Tissue oxygen saturation (StO2) upslope before during and after aPC infusion | StO2 upslope is measured with Near InfraRed Spectroscopy at the tenar muscle. It represents the velocity of the recovery of the tissue oxygen saturation after a short period of ischemia of the hand, the Vascular Occlusion Test. | 102 hours |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |