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

Phase 1

Completed

• Conditions: Severe Sepsis and Septic Shock
• Interventions: Device: EISS

• Registration Number: NCT00818597
• Lead Sponsor: University of Rostock

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2004-04
• Study Completion: 2008-06
• Status Verified: 2009-01
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-06
• Last Update Submitted: 2009-01-06
• Study First Posted: 2009-01-07
• Last Update Posted: 2009-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EISS-treatment	EISS	In this arm patients receive additional treatment with the EISS-bioreactor

Primary Outcome Measures

Name	Time	Method
single organ functions (circulation, kidney, lung, liver)	28day post inclusion

Secondary Outcome Measures

Name	Time	Method
survival	28day post inclusion

Trial Locations

Locations (1)

University of Rostock, Department of Medicine, Division of Nephrology; 🇩🇪 Rostock, Germany