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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

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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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Detailed Description

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Conditions

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Septicemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Immunoadsorption of LPS, IL-6 and C5a

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No