Renal Insufficiency or Renal Failure &or End-stage Renal DiseaseCASAKINCT02588794
Cytokine Adsorption in Sepsis and Acute Kidney Injury
A study testing CytoSorb 300 ml device (3804606CE01) in people with Renal Insufficiency or Renal Failure &or End-stage Renal Disease, run by Technical University of Munich at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency or Renal Failure &or End-stage Renal Disease
- What is being tested?
- CytoSorb 300 ml device (3804606CE01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- severe sepsis or septic shock according to ESICM guidelines not older than 24 h
Who cannot join
- preexisting renal disease KDIGO stadium 4 and 5
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Klinik für Anästhesiologie
München, Bavaria, 81675
Ralph Bogdanski, MD, +498941405472, ralph.bogdanski@tum.de
Barbara Kapfer, MD, +498941405473, b.kapfer@tum.de
About this study
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
Read the 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.
- Being tested
- CytoSorb 300 ml device (3804606CE01)
- Keywords
- sepsis, acute kidney injury , CytoSorb
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic, Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb 300 ml device (3804606CE01)Device
additional cytokine adsorber
| Study group | Role | What they receive |
|---|---|---|
| intervention | Active comparator | Standart CVVHD plus CytoSorb 300 ml device (3804606CE01) Receives: Device: CytoSorb 300 ml device (3804606CE01) |
| control | No intervention | Standart CVVHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
RIFLE stadium L or E after acute kidney injury related to sepsis
Measured: 3 months
Secondary outcomes (4)
mortality
Measured: 3 months
length of renal replacement therapy
Measured: 3 months
SOFA score
Measured: 3 months
cumulative dose of vasopressor support
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency or Renal Failure &or End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guenther_Edenharter, Technical University of Munich
- Investigators
- Kochs Eberhard, Chairman, Study chair, Department of Anaesthsiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588794
- Sponsor's protocol ID
- 316/15 S
- Acronym
- CASAKI
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption in Sepsis and Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT02588794
- Acronym / sponsor ID
- CASAKI / 316/15 S
- Keywords
- sepsis, acute kidney injury , CytoSorb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Active comparator | Device: CytoSorb 300 ml device (3804606CE01)Standart CVVHD plus CytoSorb 300 ml device (3804606CE01) |
| control | No intervention | –Standart CVVHD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- severe sepsis or septic shock according to ESICM guidelines not older than 24 h
Key exclusion criteria (1 listed)
- preexisting renal disease KDIGO stadium 4 and 5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytoSorb 300 ml device (3804606CE01)additional cytokine adsorber | Device | intervention |
Primary outcome
RIFLE stadium L or E after acute kidney injury related to sepsis
Time frame: 3 months
4 secondary outcomes
mortality
Time frame: 3 months
length of renal replacement therapy
Time frame: 3 months
SOFA score
Time frame: 3 months
cumulative dose of vasopressor support
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kochs Eberhard, Chairman study chair
Department of Anaesthsiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb 300 ml device (3804606CE01) in people with Renal Insufficiency or Renal Failure &or End-stage Renal Disease, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralph Bogdanski, MD (+498941405472, ralph.bogdanski@tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RIFLE stadium L or E after acute kidney injury related to sepsis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.