Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients - Full Text View

Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients (EISS-1)

This study has been completed.

First Received: January 5, 2009 Last Updated: January 6, 2009 History of Changes

Sponsor:	University of Rostock
Information provided by:	University of Rostock
ClinicalTrials.gov Identifier:	NCT00818597

Purpose

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.

Condition	Intervention	Phase
Severe Sepsis and Septic Shock	Device: EISS	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by University of Rostock:

Primary Outcome Measures:

single organ functions (circulation, kidney, lung, liver) [ Time Frame: 28day post inclusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

survival [ Time Frame: 28day post inclusion ] [ Designated as safety issue: Yes ]

Enrollment:	10
Study Start Date:	December 2003
Study Completion Date:	June 2008
Primary Completion Date:	April 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EISS-treatment: Experimental In this arm patients receive additional treatment with the EISS-bioreactor	Device: EISS Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

sepsis with at least one organ failure (severe sepsis) or septic shock

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00818597

Locations

Germany
University of Rostock, Department of Medicine, Division of Nephrology
Rostock, Germany, 18055

Sponsors and Collaborators

University of Rostock

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klöhr 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.

Sauer M, Altrichter J, Kreutzer HJ, Lögters T, Scholz M, Nöldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Dec 26; [Epub ahead of print]

Responsible Party:	University of Rostock, Medical Faculty ( Steffen Mitzner/ Head Division of Nephrology )
Study ID Numbers:	EISS-1
Study First Received:	January 5, 2009
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00818597 History of Changes
Health Authority:	Germany: Paul-Ehrlich-Institut; Germany: Ethics Commission

Keywords provided by University of Rostock:

septic shock
immunoparalysis
extracorporeal
granulocyte bioreactor
plasmapheresis

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Shock

Shock, Septic
Infection
Inflammation

ClinicalTrials.gov processed this record on February 08, 2010