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.

First Received on November 14, 2005. Last Updated on May 24, 2011 History of Changes

Sponsor:	Charite University, Berlin, Germany
Collaborator:	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	Biological: GM-CSF (verum)	Phase II

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:

MedlinePlus related topics: Sepsis Shock

Drug Information available for: Granulocyte-macrophage colony-stimulating factor Sargramostim

U.S. FDA Resources

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):

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. Epub 2009 Jul 9.

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 February 12, 2012