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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00818597
First Posted: January 7, 2009
Last Update Posted: January 7, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Rostock
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • survival [ Time Frame: 28day post inclusion ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: January 5, 2009
First Posted: January 7, 2009
Last Update Posted: January 7, 2009
Last Verified: January 2009

Keywords provided by University of Rostock:
septic shock
immunoparalysis
extracorporeal
granulocyte bioreactor
plasmapheresis

Additional relevant MeSH terms:
Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock