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Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GM-CSF (verum)
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis

Eligibility Criteria

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

Inclusion Criteria: Severe sepsis or septic shock, Presence of infection, 2 SIRS criteria, Acute organ dysfunction, Immunoparalysis, Informed consent Exclusion Criteria: Pregnancy, Known allergies to study medication or components, Moribound patient, Autoimmune disease, HIV-infection, Acute MI or pulmonary embolism, Cpr during last 72 hours, Patients who participate in a different clinical study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Verum

    Arm Description

    GM-CSF therapy

    Outcomes

    Primary Outcome Measures

    reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9

    Secondary Outcome Measures

    Full Information

    First Posted
    November 14, 2005
    Last Updated
    May 24, 2011
    Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Research Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00252915
    Brief Title
    Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
    Official Title
    Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock: a Prospective, Randomised, Double-blind, Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2005 (undefined)
    Primary Completion Date
    January 2007 (Actual)
    Study Completion Date
    April 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Charite University, Berlin, Germany
    Collaborators
    German Research Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    There is basic science evidence that GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patients with severe sepsis and septic shock.
    Detailed Description
    GM-CSF reconstructs cellular immunity in septic patients. In this prospective, randomised double-blind, placebo-controlled trial, we investigate whether this can be achieved in patinets with severe sepsis and septic shock.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Verum
    Arm Type
    Experimental
    Arm Description
    GM-CSF therapy
    Intervention Type
    Biological
    Intervention Name(s)
    GM-CSF (verum)
    Intervention Description
    sagramostim
    Primary Outcome Measure Information:
    Title
    reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
    Time Frame
    after therapy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Severe sepsis or septic shock, Presence of infection, 2 SIRS criteria, Acute organ dysfunction, Immunoparalysis, Informed consent Exclusion Criteria: Pregnancy, Known allergies to study medication or components, Moribound patient, Autoimmune disease, HIV-infection, Acute MI or pulmonary embolism, Cpr during last 72 hours, Patients who participate in a different clinical study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans-Dieter Volk, MD
    Organizational Affiliation
    Charite University, Berlin, Germany
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Joerg C Schefold, MD
    Organizational Affiliation
    Charite University Medicine
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Christian Meisel, MD
    Organizational Affiliation
    Charite University Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19590022
    Citation
    Meisel C, Schefold JC, Pschowski R, Baumann T, Hetzger K, Gregor J, Weber-Carstens S, Hasper D, Keh D, Zuckermann H, Reinke P, Volk HD. Granulocyte-macrophage colony-stimulating factor to reverse sepsis-associated immunosuppression: a double-blind, randomized, placebo-controlled multicenter trial. Am J Respir Crit Care Med. 2009 Oct 1;180(7):640-8. doi: 10.1164/rccm.200903-0363OC. Epub 2009 Jul 9.
    Results Reference
    derived

    Learn more about this trial

    Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock

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