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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00818597

Acronym

EISS-1

Enrollment

Registered

2009-01-07

Start date

2003-12-31

Completion date

2008-06-30

Last updated

2009-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis and Septic Shock

Keywords

septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis

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.

Interventions

DEVICEEISS

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
survival	28day post inclusion

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026