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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00146432
Enrollment
Unknown
Registered
2005-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2009-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septicemia

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

Interventions

PROCEDUREImmunoadsorption of LPS, IL-6 and C5a

Sponsors

German Research Foundation
CollaboratorOTHER
adexter GmbH
CollaboratorINDUSTRY
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026