Reconstruction of Monocytic Immunocompetence by Granulocyte-macrophage-colony Stimulating Factor (GM-CSF) in Patients With Severe Sepsis and Septic Shock
May 24, 2011 updated by: Charite University, Berlin, Germany
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
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Verum
GM-CSF therapy
|
sagramostim
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
reconstitution of monocytic immunity as defined as a mHLA-DR expression >15,000 molecules per cell at study day 9
Time Frame: after therapy
|
after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Hans-Dieter Volk, MD, Charite University, Berlin, Germany
- Principal Investigator: Joerg C Schefold, MD, Charité University Medicine
- Principal Investigator: Christian Meisel, MD, Charité University Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2005
Primary Completion (Actual)
January 1, 2007
Study Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
November 14, 2005
First Submitted That Met QC Criteria
November 14, 2005
First Posted (Estimate)
November 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 26, 2011
Last Update Submitted That Met QC Criteria
May 24, 2011
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GM-CSF-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.