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

University of Rostock

Status and phase: Completed; Phase 2; Phase 1

Conditions: Severe Sepsis and Septic Shock

Treatments: Device: EISS

Study type: Interventional

Funder types: Other

Identifiers

NCT00818597

EISS-1

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

EISS-treatment

Experimental group

Description:

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

Treatment:

Device: EISS