search
Back to results

Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C (PCA)

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Recombinant Activated Protein C
Near-infrared spectroscopy (NIRS)
Phenylephrine
Blood sample
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring vasoreactivity, recombinant activated protein C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- Patients with septic shock as determined by standard criteria (including infection and severe infection)

Exclusion Criteria:

  • Pregnant women
  • Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
  • Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Shock + Treatment

    Shock

    Arm Description

    Patients treated with activated protein C

    Patients not treated with activated protein C

    Outcomes

    Primary Outcome Measures

    Vascular reactivity measured with dose-response to phenylephrine
    Vascular reactivity measured with dose-response to phenylephrine
    Vascular reactivity measured with dose-response to phenylephrine

    Secondary Outcome Measures

    Full Information

    First Posted
    August 26, 2016
    Last Updated
    August 26, 2016
    Sponsor
    Central Hospital, Nancy, France
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02885168
    Brief Title
    Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
    Acronym
    PCA
    Official Title
    Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    April 2009 (Actual)
    Study Completion Date
    April 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Central Hospital, Nancy, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC). This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Septic Shock
    Keywords
    vasoreactivity, recombinant activated protein C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Shock + Treatment
    Arm Type
    Experimental
    Arm Description
    Patients treated with activated protein C
    Arm Title
    Shock
    Arm Type
    Other
    Arm Description
    Patients not treated with activated protein C
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant Activated Protein C
    Other Intervention Name(s)
    Xigris
    Intervention Description
    24 μg/kg/h during 96 hours - intravenous injection
    Intervention Type
    Device
    Intervention Name(s)
    Near-infrared spectroscopy (NIRS)
    Intervention Description
    After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function.
    Intervention Type
    Drug
    Intervention Name(s)
    Phenylephrine
    Intervention Description
    Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test.
    Intervention Type
    Biological
    Intervention Name(s)
    Blood sample
    Intervention Description
    Analysis of inflammation and cellular adhesion markers and free radicals
    Primary Outcome Measure Information:
    Title
    Vascular reactivity measured with dose-response to phenylephrine
    Time Frame
    baseline
    Title
    Vascular reactivity measured with dose-response to phenylephrine
    Time Frame
    4 hours
    Title
    Vascular reactivity measured with dose-response to phenylephrine
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - Patients with septic shock as determined by standard criteria (including infection and severe infection) Exclusion Criteria: Pregnant women Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruno LEVY
    Organizational Affiliation
    Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

    We'll reach out to this number within 24 hrs