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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014