Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients
EISS-1
PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
1 other identifier
interventional
10
1 country
1
Brief Summary
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Dec 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedJanuary 7, 2009
January 1, 2009
4 months
January 5, 2009
January 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
single organ functions (circulation, kidney, lung, liver)
28day post inclusion
Secondary Outcomes (1)
survival
28day post inclusion
Study Arms (1)
EISS-treatment
EXPERIMENTALIn this arm patients receive additional treatment with the EISS-bioreactor
Interventions
Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.
Eligibility Criteria
You may qualify if:
- sepsis with at least one organ failure (severe sepsis) or septic shock
You may not qualify if:
- Participation in another study within the last 30 days
- Earlier participation in this study
- Pregnancy
- Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
- Hemodynamic shock for more than 12 hours (systolic BP \<90mmHg) despite adequate therapy
- HIV infection
- HCV infection, active
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rostock, Department of Medicine, Division of Nephrology
Rostock, 18055, Germany
Related Publications (3)
Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. doi: 10.1046/j.1526-0968.2001.00378.x.
PMID: 11778929BACKGROUNDSauer M, Altrichter J, Kreutzer HJ, Logters T, Scholz M, Noldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77.
PMID: 19114920BACKGROUNDAltrichter J, Sauer M, Kaftan K, Birken T, Gloger D, Gloger M, Henschel J, Hickstein H, Klar E, Koball S, Pertschy A, Noldge-Schomburg G, Vagts DA, Mitzner SR. Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study. Crit Care. 2011;15(2):R82. doi: 10.1186/cc10076. Epub 2011 Mar 3.
PMID: 21371308DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 7, 2009
Study Start
December 1, 2003
Primary Completion
April 1, 2004
Study Completion
June 1, 2008
Last Updated
January 7, 2009
Record last verified: 2009-01