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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:


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:
Publications:
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