Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Infections+5

+ Inflammation

+ Pathologic Processes

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2009
See protocol details

Summary

Principal SponsorUniversità Politecnica delle Marche
Last updated: October 22, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2009

Actual date on which the first participant was enrolled.

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.

NCT01806428
Principal SponsorUniversità Politecnica delle Marche
Last updated: October 22, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

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

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsInflammationPathologic ProcessesShockPathological Conditions, Signs and SymptomsSystemic Inflammatory Response SyndromeShock, SepticSepsis

Criteria

1 inclusion criteria required to participate
Septic patients with at least two sepsis-induced organ failures occurring within 48 hours of the onset of sepsis
4 exclusion criteria prevent from participating
hematologic or advanced malignancies
liver cirrhosis
severely impaired consciousness (Glasgow Coma Scale score < 7 of 15)
therapeutic limitations (do-not-resuscitate orders)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, ItalyOpen University ICU, AOU Ospedali Riuniti Ancona in Google Maps
CompletedOne Study Center