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

University of Rostock10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Sepsis and Septic Shock

Interventions

EISSDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Rostock, Department of Medicine, Division of Nephrology

Rostock, Germany

Outcomes

Primary Outcomes

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

Time frame: 28day post inclusion

Secondary Outcomes

survival

Time frame: 28day post inclusion

Data from ClinicalTrials.gov

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