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Cytokine Adsorption in Sepsis and Acute Kidney Injury (CASAKI)

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

CytoSorb 300 ml device (3804606CE01)

About this trial

This is an interventional treatment trial for Renal Insufficiency or Renal Failure &or End-stage Renal Disease focused on measuring sepsis, acute kidney injury , CytoSorb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Klinik für AnästhesiologieRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

intervention

control

Arm Description

Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)

Standart CVVHD

Outcomes

Primary Outcome Measures

RIFLE stadium L or E after acute kidney injury related to sepsis

Secondary Outcome Measures

mortality

length of renal replacement therapy

SOFA score

cumulative dose of vasopressor support

Full Information

NCT ID

NCT02588794

First Posted

October 27, 2015

Last Updated

October 27, 2015

Sponsor

Technical University of Munich

1. Study Identification

Unique Protocol Identification Number

NCT02588794

Brief Title

Cytokine Adsorption in Sepsis and Acute Kidney Injury

Acronym

CASAKI

Official Title

Cytokine Adsorption in Sepsis and Acute Kidney Injury

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

October 2015 (undefined)

Primary Completion Date

August 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Technical University of Munich

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

sepsis, acute kidney injury , CytoSorb

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

intervention

Arm Type

Active Comparator

Arm Description

Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)

Arm Title

control

Arm Type

No Intervention

Arm Description

Standart CVVHD

Intervention Type

Device

Intervention Name(s)

CytoSorb 300 ml device (3804606CE01)

Intervention Description

additional cytokine adsorber

Primary Outcome Measure Information:

Title

RIFLE stadium L or E after acute kidney injury related to sepsis

Time Frame

3 months

Secondary Outcome Measure Information:

Title

mortality

Time Frame

3 months

Title

length of renal replacement therapy

Time Frame

3 months

Title

SOFA score

Time Frame

3 months

Title

cumulative dose of vasopressor support

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ralph Bogdanski, MD

Phone

+498941405472

ralph.bogdanski@tum.de

First Name & Middle Initial & Last Name or Official Title & Degree

Barbara Kapfer, MD

Phone

+498941405473

b.kapfer@tum.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kochs Eberhard, Chairman

Organizational Affiliation

Department of Anaesthsiology

Official's Role

Study Chair

Facility Information:

Facility Name

Klinik für Anästhesiologie

City

München

State/Province

Bayern

ZIP/Postal Code

81675

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ralph Bogdanski, MD

Phone

+498941405472

ralph.bogdanski@tum.de

First Name & Middle Initial & Last Name & Degree

Barbara Kapfer, MD

Phone

+498941405473

b.kapfer@tum.de

First Name & Middle Initial & Last Name & Degree

Markus Heim, MD

First Name & Middle Initial & Last Name & Degree

Günther Edenharter, MD

12. IPD Sharing Statement

Learn more about this trial

Cytokine Adsorption in Sepsis and Acute Kidney Injury

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