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Completed

NCT Number: NCT00818597

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

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.

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Key information

Conditions

Severe Sepsis and Septic Shock Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Rostock, Department of Medicine, Division of Nephrology

Rostock, 18055, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EISS

Device

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

Primary outcomes

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

    Time frame: 28day post inclusion

Secondary outcomes

  1. survival

    Time frame: 28day post inclusion

Sponsors and collaborators

Lead sponsor

University of Rostock

Other

Registry information

Official study title

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

Acronym: EISS-1

Important dates

Study start
2003
Primary completion
2004
Study completion
2008
First posted
Jan 7, 2009
Registry last updated
Jan 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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