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

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ClinicalTrials.gov Identifier: NCT00252915
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 26, 2011
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany

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.

Condition or disease Intervention/treatment Phase
Sepsis Biological: GM-CSF (verum) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Verum
GM-CSF therapy
Biological: GM-CSF (verum)
sagramostim



Primary Outcome Measures :
  1. reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9 [ Time Frame: after therapy ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252915


Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Investigators
Study Chair: Hans-Dieter Volk, MD Charite University, Berlin, Germany
Principal Investigator: Joerg C Schefold, MD Charite University Medicine
Principal Investigator: Christian Meisel, MD Charite University Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charite University Medicine Berlin, Charite
ClinicalTrials.gov Identifier: NCT00252915     History of Changes
Other Study ID Numbers: GM-CSF-1
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: July 2009

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock