Activated Protein C and Microcirculation

Study Overview
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Brief Summary
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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.

Official Title
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THE Activated Protein C (aPC) TREATMENT IMPROVES MICROCIRCULATION IN SEVERE SEPSIS/ SEPTIC SHOCK SYNDROME

Conditions
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Severe Sepsis, Septic Shock

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis Exclusion Criteria: hematologic or advanced malignancies liver cirrhosis severely impaired consciousness (Glasgow Coma Scale score <7 of 15) therapeutic limitations (do-not-resuscitate orders)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| aPC treatment group<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |