Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients (EISS-1)
This study has been completed.
Sponsor:
University of Rostock
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00818597
First received: January 5, 2009
Last updated: January 6, 2009
Last verified: January 2009
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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 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 May 16, 2013