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

This study has been completed.
Sponsor:
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00818597
First received: January 5, 2009
Last updated: January 6, 2009
Last verified: January 2009
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Experimental: EISS-treatment
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Steffen Mitzner/ Head Division of Nephrology, University of Rostock, Medical Faculty
ClinicalTrials.gov Identifier: NCT00818597     History of Changes
Other Study ID Numbers: EISS-1
Study First Received: January 5, 2009
Last Updated: January 6, 2009
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:
Sepsis
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014