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Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

Primary Purpose

Hemoperfusion, Multiorgan Failure, Sepsis

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Extracorporeal support with haemoperfusion
Conventional treatment
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemoperfusion

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:
  • Sepsis of abdominal origin with controlled infectious focus.
  • Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy.
  • Dysfunction of two or more organs with SOFA ≥ 9 (5).
  • Blood lactate ≥ 2 mmol / L.
  • Procalcitonin (PCT)> 10 ng / mL.
  • CRP> 100 mg / L.
  • IL-6> 2000 pg / ml.

Exclusion Criteria:

  • Age under 18 years or over 80 years.
  • Pregnancy or breastfeeding.
  • Terminally ill patients or with a life expectancy of less than 48 hours.
  • Thrombocytopenia <60,000 / mm3.
  • Pancytopenia.
  • Severe coagulopathy with high risk of bleeding.
  • Inclusion in another research protocol.
  • In case of re-entry during the study period, only the first admission will be included.
  • Use of another haemoperfusion device.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional treatment

    Extracorporeal support with haemoperfusion treatment

    Arm Description

    Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.

    Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.

    Outcomes

    Primary Outcome Measures

    Vasopressors dose
    Analyze the patient's vasopressor dose during the hemoperfusion process
    Vasopressors dose - Intensive Care Unit discharge
    Analyze the patient's vasopressor dose prior Intensive Care Unit discharge
    Vasopressors dose - Hospital discharge
    Analyze the patient's vasopressor dose prior Hospital discharge
    Vasopressors dose - 90 days post-Intensive Care Unit discharge
    Analyze the patient's vasopressor dose 90 days post-Intensive Care Unit discharge

    Secondary Outcome Measures

    Full Information

    First Posted
    August 3, 2021
    Last Updated
    September 6, 2021
    Sponsor
    Hospital Clinic of Barcelona
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05044403
    Brief Title
    Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin
    Official Title
    Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital Clinic of Barcelona

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with multiorgan dysfunction syndrome by septic origin.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemoperfusion, Multiorgan Failure, Sepsis

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients receiving conventional treatment for multiorganic dysfunction syndrome from septic origin.
    Arm Title
    Extracorporeal support with haemoperfusion treatment
    Arm Type
    Experimental
    Arm Description
    Patients receiving extracorporeal support with haemoperfusion for multiorganic dysfunction syndrome from septic origin.
    Intervention Type
    Procedure
    Intervention Name(s)
    Extracorporeal support with haemoperfusion
    Intervention Description
    Use of extracorporeal support with haemoperfusion
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional treatment
    Intervention Description
    Conventional treatment
    Primary Outcome Measure Information:
    Title
    Vasopressors dose
    Description
    Analyze the patient's vasopressor dose during the hemoperfusion process
    Time Frame
    During hemoperfusion
    Title
    Vasopressors dose - Intensive Care Unit discharge
    Description
    Analyze the patient's vasopressor dose prior Intensive Care Unit discharge
    Time Frame
    Prior Intensive Care Unit discharge
    Title
    Vasopressors dose - Hospital discharge
    Description
    Analyze the patient's vasopressor dose prior Hospital discharge
    Time Frame
    Prior Hospital discharge
    Title
    Vasopressors dose - 90 days post-Intensive Care Unit discharge
    Description
    Analyze the patient's vasopressor dose 90 days post-Intensive Care Unit discharge
    Time Frame
    90 days post-Intensive Care Unit discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions: Sepsis of abdominal origin with controlled infectious focus. Noradrenaline dose> 0.5 µg / kg / min to maintain adequate organ perfusion after optimization of fluid therapy. Dysfunction of two or more organs with SOFA ≥ 9 (5). Blood lactate ≥ 2 mmol / L. Procalcitonin (PCT)> 10 ng / mL. CRP> 100 mg / L. IL-6> 2000 pg / ml. Exclusion Criteria: Age under 18 years or over 80 years. Pregnancy or breastfeeding. Terminally ill patients or with a life expectancy of less than 48 hours. Thrombocytopenia <60,000 / mm3. Pancytopenia. Severe coagulopathy with high risk of bleeding. Inclusion in another research protocol. In case of re-entry during the study period, only the first admission will be included. Use of another haemoperfusion device.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fernando Sánchez Morán
    Phone
    964399914
    Email
    fsanchez201x@cv.gva.es

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of the Efficacy and Safety of Extracorporeal Support With Hemoperfusion in Critical Patients With Multiorgan Dysfunction Syndrome by Septic Origin

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