Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients (EISS-1)

January 6, 2009 updated by: University of Rostock

PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Rostock, Germany, 18055
        • University of Rostock, Department of Medicine, Division of Nephrology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
single organ functions (circulation, kidney, lung, liver)
Time Frame: 28day post inclusion
28day post inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
survival
Time Frame: 28day post inclusion
28day post inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rostock

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

January 5, 2009

First Submitted That Met QC Criteria

January 6, 2009

First Posted (Estimate)

January 7, 2009

Study Record Updates

Last Update Posted (Estimate)

January 7, 2009

Last Update Submitted That Met QC Criteria

January 6, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EISS-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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