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

Primary Purpose

Severe Sepsis and Septic Shock

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
EISS
Sponsored by
University of Rostock
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis and Septic Shock focused on measuring septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EISS-treatment

Arm Description

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

Outcomes

Primary Outcome Measures

single organ functions (circulation, kidney, lung, liver)

Secondary Outcome Measures

survival

Full Information

First Posted
January 5, 2009
Last Updated
January 6, 2009
Sponsor
University of Rostock
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1. Study Identification

Unique Protocol Identification Number
NCT00818597
Brief Title
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Rostock

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis and Septic Shock
Keywords
septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EISS-treatment
Arm Type
Experimental
Arm Description
In this arm patients receive additional treatment with the EISS-bioreactor
Intervention Type
Device
Intervention Name(s)
EISS
Intervention Description
Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.
Primary Outcome Measure Information:
Title
single organ functions (circulation, kidney, lung, liver)
Time Frame
28day post inclusion
Secondary Outcome Measure Information:
Title
survival
Time Frame
28day post inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Rostock, Department of Medicine, Division of Nephrology
City
Rostock
ZIP/Postal Code
18055
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
11778929
Citation
Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr 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. doi: 10.1046/j.1526-0968.2001.00378.x.
Results Reference
background
PubMed Identifier
19114920
Citation
Sauer M, Altrichter J, Kreutzer HJ, Logters T, Scholz M, Noldge-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.
Results Reference
background
PubMed Identifier
21371308
Citation
Altrichter J, Sauer M, Kaftan K, Birken T, Gloger D, Gloger M, Henschel J, Hickstein H, Klar E, Koball S, Pertschy A, Noldge-Schomburg G, Vagts DA, Mitzner SR. Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study. Crit Care. 2011;15(2):R82. doi: 10.1186/cc10076. Epub 2011 Mar 3.
Results Reference
derived
Links:
URL
http://www.nephrologie.med.uni-rostock.de/
Description
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Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients

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