Cytokine Adsorption in Sepsis and Acute Kidney Injury | NCT02588794

Studies
Cytokine Adsorption in Sepsis and Acute Kidney Injury

NCT02588794

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Oct 28, 2015Estimated

Enrollment

124Estimated

Phase

Not Applicable

Conditions

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

Interventions

CytoSorb 300 ml device (3804606CE01)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Aug 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Oct 27, 2015

First Submission Date that Met QC Criteria

Oct 27, 2015

First Posted Date

Oct 28, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2015

Last Update Posted Date

Oct 28, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Guenther_Edenharter, Dr.med., Technical University of MunichPrincipal Investigator

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intervention	Active Comparator	Standart CVVHD plus CytoSorb 300 ml device (3804606CE01)	Device: CytoSorb 300 ml device (3804606CE01)
control	No Intervention	Standart CVVHD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CytoSorb 300 ml device (3804606CE01)	Device	additional cytokine adsorber	intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
mortality		3 months
length of renal replacement therapy		3 months
SOFA score

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ralph Bogdanski, MD	Contact	+498941405472		ralph.bogdanski@tum.de
Barbara Kapfer, MD	Contact	+498941405473		b.kapfer@tum.de

Overall Officials

Name	Affiliation	Role
Kochs Eberhard, Chairman	Department of Anaesthsiology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesiologie	Recruiting	München	Bavaria	81675	Germany

Condition Browse Module

MeSH Terms

ID	Term
D051437	Renal Insufficiency
D007676	Kidney Failure, Chronic
D018805	Sepsis
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided