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

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00252915
First received: November 14, 2005
Last updated: May 24, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Sepsis
Biological: GM-CSF (verum)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9 [ Time Frame: after therapy ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: November 2005
Study Completion Date: April 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verum
GM-CSF therapy
Biological: GM-CSF (verum)
sagramostim

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Charite University, Berlin, Germany

Additional 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
Study First Received: November 14, 2005
Last Updated: May 24, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on April 17, 2014