Activated Protein C and Microcirculation

Università Politecnica delle Marche

Status: Completed

Conditions: Severe Sepsis; Septic Shock

Study type: Observational

Funder types: Other

Identifiers

NCT01806428

208249

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

22 participants in 2 patient groups

aPC treatment group

Description:

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

Description:

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