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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Severe Sepsis and Septic Shock

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EISS-treatment

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

Group Type EXPERIMENTAL

EISS

Intervention Type DEVICE

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

Interventions

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EISS

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No