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

Charité University Medicine Berlin logo

Charité University Medicine Berlin

Status and phase

Completed
Phase 3
Phase 2

Conditions

Septicemia

Treatments

Procedure: Immunoadsorption of LPS, IL-6 and C5a

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00146432
ISASS-1

Details and patient eligibility

About

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

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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