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

Severe Sepsis and Septic Shock Clinical Trial

— EISS-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818597
• Other study ID #: EISS-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 5, 2009
• Last updated: January 6, 2009
• Start date: December 2003
• Est. completion date: June 2008

Study information

• Verified date: January 2009
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-InstitutGermany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2008
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Severe Sepsis and Septic Shock
• Shock, Septic

Intervention

Device:
• EISS
Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.

Locations

Country	Name	City	State
Germany	University of Rostock, Department of Medicine, Division of Nephrology	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klöhr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. — View Citation

Sauer M, Altrichter J, Kreutzer HJ, Lögters T, Scholz M, Nöldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	single organ functions (circulation, kidney, lung, liver)		28day post inclusion	Yes
Secondary	survival		28day post inclusion	Yes

External Links

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