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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014