Activated Protein C and Microcirculation

October 20, 2013 updated by: Abele Donati, MD, Università Politecnica delle Marche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Ancona
      • Torrette di Ancona, Ancona, Italy, 60126
        • University ICU, AOU Ospedali Riuniti Ancona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microcirculatory Flow Index (MFI) before during and after aPC infusion
Time Frame: 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.
102 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perfused Vessel Density before during and after aPC infusion
Time Frame: 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.
102 hours
Tissue oxygen saturation (StO2) upslope before during and after aPC infusion
Time Frame: 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.
102 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Politecnica delle Marche

Collaborators

Azienda Ospedaliero, Universitaria Ospedali Riuniti

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

March 6, 2013

First Submitted That Met QC Criteria

March 6, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 22, 2013

Last Update Submitted That Met QC Criteria

October 20, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 208249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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