Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

October 27, 2015 updated by: Guenther_Edenharter, Technical University of Munich
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bayern
      • München, Bayern, Germany, 81675
        • Recruiting
        • Klinik für Anästhesiologie
        • Contact:
        • Contact:
        • Principal Investigator:
          • Markus Heim, MD
        • Principal Investigator:
          • Günther Edenharter, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: intervention
Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)
Device: CytoSorb 300 ml device (3804606CE01)
additional cytokine adsorber
NO_INTERVENTION: control
Standart CVVHD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
RIFLE stadium L or E after acute kidney injury related to sepsis
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 3 months
3 months
length of renal replacement therapy
Time Frame: 3 months
3 months
SOFA score
Time Frame: 3 months
3 months
cumulative dose of vasopressor support
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Chair: Kochs Eberhard, Chairman, Department of Anaesthsiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (ESTIMATE)

October 28, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 27, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316/15 S

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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