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

Primary Purpose

Septicemia

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Immunoadsorption of LPS, IL-6 and C5a

About this trial

This is an interventional treatment trial for Septicemia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All Sexes

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)

Sites / Locations

Charite University Medicine Berlin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00146432

First Posted

September 6, 2005

Last Updated

August 21, 2009

Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Foundation, adexter GmbH

1. Study Identification

Unique Protocol Identification Number

NCT00146432

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2009

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Charite University, Berlin, Germany

Collaborators

German Research Foundation, adexter GmbH

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Septicemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Immunoadsorption of LPS, IL-6 and C5a

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petra Reinke, MD, PhD

Organizational Affiliation

Charite, University Medicine Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charite University Medicine Berlin

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

17558345

Citation

Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25. doi: 10.1097/shk.0b013e31804f5921.

Results Reference

derived

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/18448264?ordinalpos=14&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_DefaultReportPanel.Pubmed_RVDocSum

Description

Related Info

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

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