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Reconstruction of Monocytic Immunocompetence by GM-CSF in Patients With Severe Sepsis and Septic Shock

This study has been completed.

Sponsors and Collaborators: Charite University, Berlin, Germany
German Research Foundation
Information provided by: Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00252915
  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 Immunoparalysis
Drug: GM-CSF (verum)
Phase II

MedlinePlus related topics:   Sepsis   

ChemIDplus related topics:   Sargramostim    Granulocyte-macrophage colony-stimulating factor   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

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

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

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

Locations
Germany
Charite University Medicine    
      Berlin, Germany, 13353

Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation

Investigators
Principal Investigator:     Hans-Dieter Volk, Prof. Dr.     Charite University Medicine Berlin    
  More Information

Study ID Numbers:   GM-CSF-1
First Received:   November 14, 2005
Last Updated:   May 15, 2007
ClinicalTrials.gov Identifier:   NCT00252915
Health Authority:   Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Sepsis
Shock
Shock, Septic
Inflammation

Additional relevant MeSH terms:
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on September 04, 2008




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