Cytokine Adsorption in Sepsis and Acute Kidney Injury

NCT ID: NCT02588794

Last Updated: 2015-10-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-12-31

Brief Summary

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Aim of the study is to reduce the incidence of RIFLE stadium L and E after acute kidney injury in patients with severe sepsis/septic shock

Detailed Description

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Patient with proved severe sepsis/septic shock, treated in accordance to actual sepsis guidelines, who develope akute kidney injury (RIFLE I) or kidney failure (RIFLE F), were randomized in two groups.

One group is treated with CVVHD/ local citrat anticoagulation (standart clinical practice).

The other group ist treated with an additional cytokine adsorber ( 300ml CytoSorb device, 3804606CE01)

CytoSorb therapy is performed for 24h, then the adsorber is changed into a new device.

Cytosorb therapy is stopped, when Interleukin 6 leves drop below 1000 pg/ml in patient serum.

Conditions

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Renal Insufficiency or Renal Failure &or End-stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention

Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)

Group Type ACTIVE_COMPARATOR

CytoSorb 300 ml device (3804606CE01)

Intervention Type DEVICE

additional cytokine adsorber

control

Standart CVVHD

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CytoSorb 300 ml device (3804606CE01)

additional cytokine adsorber

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* severe sepsis or septic shock according to ESICM guidelines not older than 24 h

Exclusion Criteria

* preexisting renal disease KDIGO stadium 4 and 5
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Guenther_Edenharter

Dr.med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kochs Eberhard, Chairman

Role: STUDY_CHAIR

Department of Anaesthsiology

Locations

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Klinik für Anästhesiologie

München, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Ralph Bogdanski, MD

Role: CONTACT

+498941405472

Barbara Kapfer, MD

Role: CONTACT

+498941405473

Facility Contacts

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Ralph Bogdanski, MD

Role: primary

+498941405472

Barbara Kapfer, MD

Role: backup

+498941405473

Other Identifiers

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316/15 S

Identifier Type: -

Identifier Source: org_study_id

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