Activated Protein C and Microcirculation

Septic Shock Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806428
• Other study ID #: 208249
• Status: Completed
• Phase: N/A
• First received: March 6, 2013
• Last updated: October 20, 2013
• Start date: July 2009
• Est. completion date: August 2011

Study information

• Verified date: October 2013
• Source: Università Politecnica delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Septic Shock
• Severe Sepsis
• Shock, Septic

Locations

Country	Name	City	State
Italy	University ICU, AOU Ospedali Riuniti Ancona	Torrette di Ancona	Ancona

Sponsors (2)

Lead Sponsor	Collaborator
Università Politecnica delle Marche	Azienda Ospedaliero, Universitaria Ospedali Riuniti

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Donati A, Damiani E, Botticelli L, Adrario E, Lombrano MR, Domizi R, Marini B, Van Teeffelen JW, Carletti P, Girardis M, Pelaia P, Ince C. The aPC treatment improves microcirculation in severe sepsis/septic shock syndrome. BMC Anesthesiol. 2013 Sep 26;13( — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microcirculatory Flow Index (MFI) before during and after aPC infusion	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	No
Secondary	Perfused Vessel Density before during and after aPC infusion	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	No
Secondary	Tissue oxygen saturation (StO2) upslope before during and after aPC infusion	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	No