Activated Protein C and Microcirculation

Completed

• Conditions: Severe Sepsis; Septic Shock

• Registration Number: NCT01806428
• Lead Sponsor: Università Politecnica delle Marche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2011-08
• Study First Submitted: 2013-03-06
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-20
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microcirculatory Flow Index (MFI) before during and after aPC infusion	102 hours	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.

Secondary Outcome Measures

Name	Time	Method
Tissue oxygen saturation (StO2) upslope before during and after aPC infusion	102 hours	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.
Perfused Vessel Density before during and after aPC infusion	102 hours	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.

Trial Locations

Locations (1)

University ICU, AOU Ospedali Riuniti Ancona; 🇮🇹 Torrette di Ancona, Ancona, Italy