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OpenTrials
Completed

NCT Number: NCT01806428

Activated Protein C and Microcirculation

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, Ancona, 60126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Collaborators

  • Azienda Ospedaliero, Universitaria Ospedali Riuniti

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Mar 7, 2013
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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