Activated Protein C and Microcirculation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01806428

Enrollment

Registered

2013-03-07

Start date

2009-07-31

Completion date

2011-08-31

Last updated

2013-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock, Severe Sepsis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Italy

Outcome results