Activated Protein C and Microcirculation

NCT01806428 | Completed

• 1 other identifier: 208249
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Perfused Vessel Density before during and after aPC infusion

  102 hours

• Tissue oxygen saturation (StO2) upslope before during and after aPC infusion

  102 hours

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• hematologic or advanced malignancies
• liver cirrhosis
• severely impaired consciousness (Glasgow Coma Scale score \<7 of 15)
• therapeutic limitations (do-not-resuscitate orders)

Sponsors & Collaborators

• Università Politecnica delle Marche: lead
• Azienda Ospedaliero, Universitaria Ospedali Riuniti: collaborator

Study Sites (1)

University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, Ancona, 60126, Italy

Location

Related 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(1):25. doi: 10.1186/1471-2253-13-25.

  PMID: 24070065 RESULT

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 7, 2013
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: August 1, 2011
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

IT (1)