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OpenTrials
Completed

NCT Number: NCT00146432

Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)

The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock

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Key information

Conditions

Septicemia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Charite University Medicine Berlin

Berlin, State of Berlin, 13353, Germany

Who can participate

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

Inclusion criteria

  • Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
  • Presence of 4 SIRS criteria/indicators
  • Suspected or proven infection (refer also to: 1.)
  • Age 18-80
  • APACHE II score > 18
  • At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)

Exclusion criteria

  • Suspected or proven pregnancy
  • Absolute contraindication for anticoagulation (active bleeding)
  • Absolute IgA-deficiency
  • History of anaphylactic reaction to egg-albumin
  • Participants in other clinical trials (<12 wks. prior to study inclusion)

Treatment and study plan

Immunoadsorption of LPS, IL-6 and C5a

Procedure

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Research Foundation
  • adexter GmbH

Registry information

Official study title

Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a

Important dates

First posted
Sep 7, 2005
Registry last updated
Aug 25, 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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