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

Tracking Information

First Received Date ^ICMJE

November 14, 2005

Last Updated Date

July 13, 2009

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00252915 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Sepsis Immunoparalysis

Intervention ^ICMJE

Drug: GM-CSF (verum)

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00252915

Responsible Party

Study ID Numbers ^ICMJE

GM-CSF-1

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

German Research Foundation

Investigators ^ICMJE

Study Chair:	Hans-Dieter Volk, MD	Charite University Medicine Berlin
Principal Investigator:	Joerg C Schefold, MD	Charite University Medicine
Principal Investigator:	Christian Meisel, MD	Charite University Medicine

Information Provided By

Charite University, Berlin, Germany

Verification Date

July 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP