Activated Protein C and Microcirculation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Sepsis Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Abele Donati, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, Ancona, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type RESULT

PMID: 24070065 (View on PubMed)

Other Identifiers

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208249

Identifier Type: -

Identifier Source: org_study_id