SepsisCytoSorbNCT02312024
International Registry on the Use of the CytoSorb Adsorber
An observational study of Sepsis and Need of Cardiac Surgery, run by Jena University Hospital at 19 sites in 3 countries.
Trial summary
Registry on the use of the CytoSorb® adsorber in ICU patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Need of Cardiac Surgery
- What is being tested?
- Use of CytoSorb adsorber
- Type of treatment
- Medical device
- How many people
- 1,434 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Jan 2015to 4 Feb 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing treatment with the CytoSorb® adsorber
Who may be able to join
- Use of the CytoSorb® adsorber
- Age ≥ 18 years
- Signed informed consent
Who cannot join
- none
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
Germany17 sites
Vivantes Klinikum Neukölln
Berlin
Evangelisches Krankenhaus
Bielefeld
Carl-Thiem-Klinikum
Cottbus
Universitätsklinikum Düsseldorf
Düsseldorf
Klinikum Emden
Emden
Kliniken Erlabrunn gGmbH
Erlabrunn
Universitätsklinikum Freiburg
Freiburg im Breisgau
Universitätsmedizin Göttingen
Göttingen
Greifswald University Hospital
Greifswald
Krankenhaus St. Elisabeth & St. Barbara
Halle
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH
Herzberg
Kliniken Maria Hilf GmbH Mönchengladbach
Mönchengladbach
Klinikum rechts der Isar der TU München
München
Klinikum Oldenburg
Oldenburg
University Hospital Ulm
Ulm
Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden
About this study
Official title: International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
Registry on the use of the CytoSorb® adsorber in ICU patients.
Read the detailed description
The aim of this registry is to record the use of CytoSorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). All CytoSorb® applications in different clinical settings and in all patients who are treated with this technology in Germany, Austria and Switzerland (target population) are planned to be included.
The objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. The gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of CytoSorb®. The registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters.
The registry will inform physicians of different medical specialties about the range of possible applications of CytoSorb® and invite them to contribute their own experiences to the registry. This is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties)
The CytoSorb® registry will provide the data base for justified and optimized decisions. An active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose.
Registry data might help closing knowledge gaps and open practical issues. Due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. Registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape.
Institutions that contribute data to the registry benefit in several ways: They will obtain a continuous retrospective feedback of their own results, their data will be periodically compared with data from other participating sites, and they will get access to regularly published analyses of the results of all participants. On the basis of these data, they can establish a quality monitoring and optimize their use of CytoSorb®.
The planned endpoints allow for a comprehensive description of CytoSorb® efficacy in terms of several indication-relevant aspects. Together with the monitoring of application safety, these data build the basis for establishing benchmarks that promote a higher treatment quality.
- Conditions
- Sepsis, Need of Cardiac Surgery
- Being tested
- Use of CytoSorb adsorber
- Keywords
- CytoSorb adsorber, sepsis, cytokines, hemofiltration, hemadsorption, inflammation
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of CytoSorb adsorberDevice
Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe sepsis/septic shock | Use of CytoSorb adsorber in patients with severe sepsis/septic shock Receives: Device: Use of CytoSorb adsorber | |
| Cardiac surgery with CPB: preemptive use | Use of CytoSorb adsorber in patients with cardiac surgery with CPB: preemptive use | |
| Cardiac surgery with CPB: postop. use | Use of CytoSorb adsorber in patients with cardiac surgery with CPB: postoperative use | |
| Patients with other indications | Use of CytoSorb adsorber in patients with other indications Receives: Device: Use of CytoSorb adsorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
Measured: days
Secondary outcomes (6)
- Organ function (SOFA - score-difference)
Measured: days
- Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin
Measured: days
- Length of hospital and ICU stay (days)
Measured: days
- Duration of mechanical ventilation (days)
Measured: days
- Duration of renal replacement therapy (days)
Measured: days
- Duration of vasopressor therapy (days)
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startJan 2015
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,434 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Jena University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Goettingen
- Responsible party
- Sponsor
- Investigators
- Frank M. Brunkhorst, Prof., Principal investigator, Center for Clinical Studies at Jena University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312024
- Sponsor's protocol ID
- JenaUH
- Acronym
- CytoSorb
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2014
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hawchar F, Tomescu D, Trager K, Joskowiak D, Kogelmann K, Soukup J, Friesecke S, Jacob D, Gummert J, Faltlhauser A, Aucella F, van Tellingen M, Malbrain MLNG, Bogdanski R, Weiss G, Herbrich A, Utzolino S, Nierhaus A, Baumann A, Hartjes A, Henzler D, Grigoryev E, Fritz H, Bach F, Schroder S, Weyland A, Gottschaldt U, Menzel M, Zachariae O, Novak R, Berden J, Haake H, Quintel M, Kloesel S, Kortgen A, Stecher S, Torti P, Nestler F, Nitsch M, Olboeter D, Muck P, Findeisen M, Bitzinger D, Krassler J, Benad M, Schott M, Schumacher U, Molnar Z, Brunkhorst FM. Hemoadsorption in the critically ill-Final results of the International CytoSorb Registry. PLoS One. 2022 Oct 25;17(10):e0274315. doi: 10.1371/journal.pone.0274315. eCollection 2022.
PubMed 36282800Schittek GA, Zoidl P, Eichinger M, Orlob S, Simonis H, Rief M, Metnitz P, Fellinger T, Soukup J. Adsorption therapy in critically ill with septic shock and acute kidney injury: a retrospective and prospective cohort study. Ann Intensive Care. 2020 Nov 18;10(1):154. doi: 10.1186/s13613-020-00772-7.
PubMed 33206229Friesecke S, Trager K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.
PubMed 28871441
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
- ClinicalTrials.gov ID
- NCT02312024
- Acronym / sponsor ID
- CytoSorb / JenaUH
- Conditions
- Sepsis, Need of Cardiac Surgery
- Keywords
- CytoSorb adsorber, sepsis, cytokines, hemofiltration, hemadsorption, inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,434 participants (actual)
- Lead sponsor
- Jena University HospitalUniversity, hospital or other
- Collaborators
- University Hospital Goettingen
- Study start
- Jan 2015
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 9 Dec 2014 (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.
Registry on the use of the CytoSorb® adsorber in ICU patients.
Detailed description
The aim of this registry is to record the use of CytoSorb® under real life conditions in as many cases as possible (preferably all or, at least, in a representative sample). All CytoSorb® applications in different clinical settings and in all patients who are treated with this technology in Germany, Austria and Switzerland (target population) are planned to be included.
The objectives of the registry are collection of real-life data on a broad scale, their centralized, structured and comprehensive documentation, and a controlled data exchange. The gathered information will be used to augment the knowledge on the clinical efficacy of the technology, to optimize the quality of its therapeutic application, and to identify and promptly handle possible complications related to the use of CytoSorb®. The registry will record all relevant information in the course of product use, e.g. diagnosis, comorbidities, course of the condition, treatment, concomitant medication and clinical laboratory parameters.
The registry will inform physicians of different medical specialties about the range of possible applications of CytoSorb® and invite them to contribute their own experiences to the registry. This is done by giving them access to their own data and to the results of periodic analyses (for contributing participants), and via publications of the results (for participants and external interested parties)
The CytoSorb® registry will provide the data base for justified and optimized decisions. An active form of data collection where data is prospectively collected by qualified staff is particularly suited for this purpose.
Registry data might help closing knowledge gaps and open practical issues. Due to the patient group's heterogeneity, the registry can identify sub-groups, assess their risk-benefit-profile and examine their safety profile. Registry data are absolutely essential for assessing a therapy's significance within the healthcare landscape.
Institutions that contribute data to the registry benefit in several ways: They will obtain a continuous retrospective feedback of their own results, their data will be periodically compared with data from other participating sites, and they will get access to regularly published analyses of the results of all participants. On the basis of these data, they can establish a quality monitoring and optimize their use of CytoSorb®.
The planned endpoints allow for a comprehensive description of CytoSorb® efficacy in terms of several indication-relevant aspects. Together with the monitoring of application safety, these data build the basis for establishing benchmarks that promote a higher treatment quality.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with severe sepsis/septic shock | – | Device: Use of CytoSorb adsorberUse of CytoSorb adsorber in patients with severe sepsis/septic shock |
| Cardiac surgery with CPB: preemptive use | – | –Use of CytoSorb adsorber in patients with cardiac surgery with CPB: preemptive use |
| Cardiac surgery with CPB: postop. use | – | –Use of CytoSorb adsorber in patients with cardiac surgery with CPB: postoperative use |
| Patients with other indications | – | Device: Use of CytoSorb adsorberUse of CytoSorb adsorber in patients with other indications |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing treatment with the CytoSorb® adsorber
Key inclusion criteria (3 listed)
- Use of the CytoSorb® adsorber
- Age ≥ 18 years
- Signed informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Use of CytoSorb adsorberUse of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients. | Device | Patients with other indications, Patients with severe sepsis/septic shock |
Primary outcome
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention
Time frame: days
6 secondary outcomes
- Organ function (SOFA - score-difference)
Time frame: days
- Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin
Time frame: days
- Length of hospital and ICU stay (days)
Time frame: days
- Duration of mechanical ventilation (days)
Time frame: days
- Duration of renal replacement therapy (days)
Time frame: days
- Duration of vasopressor therapy (days)
Time frame: days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Background: PubMed 36282800Hawchar F, Tomescu D, Trager K, Joskowiak D, Kogelmann K, Soukup J, Friesecke S, Jacob D, Gummert J, Faltlhauser A, Aucella F, van Tellingen M, Malbrain MLNG, Bogdanski R, Weiss G, Herbrich A, Utzolino S, Nierhaus A, Baumann A, Hartjes A, Henzler D, Grigoryev E, Fritz H, Bach F, Schroder S, Weyland A, Gottschaldt U, Menzel M, Zachariae O, Novak R, Berden J, Haake H, Quintel M, Kloesel S, Kortgen A, Stecher S, Torti P, Nestler F, Nitsch M, Olboeter D, Muck P, Findeisen M, Bitzinger D, Krassler J, Benad M, Schott M, Schumacher U, Molnar Z, Brunkhorst FM. Hemoadsorption in the critically ill-Final results of the International CytoSorb Registry. PLoS One. 2022 Oct 25;17(10):e0274315. doi: 10.1371/journal.pone.0274315. eCollection 2022.
- Derived from this study: PubMed 33206229Schittek GA, Zoidl P, Eichinger M, Orlob S, Simonis H, Rief M, Metnitz P, Fellinger T, Soukup J. Adsorption therapy in critically ill with septic shock and acute kidney injury: a retrospective and prospective cohort study. Ann Intensive Care. 2020 Nov 18;10(1):154. doi: 10.1186/s13613-020-00772-7.
- Derived from this study: PubMed 28871441Friesecke S, Trager K, Schittek GA, Molnar Z, Bach F, Kogelmann K, Bogdanski R, Weyland A, Nierhaus A, Nestler F, Olboeter D, Tomescu D, Jacob D, Haake H, Grigoryev E, Nitsch M, Baumann A, Quintel M, Schott M, Kielstein JT, Meier-Hellmann A, Born F, Schumacher U, Singer M, Kellum J, Brunkhorst FM. International registry on the use of the CytoSorb(R) adsorber in ICU patients : Study protocol and preliminary results. Med Klin Intensivmed Notfmed. 2019 Nov;114(8):699-707. doi: 10.1007/s00063-017-0342-5. Epub 2017 Sep 4.
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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.
Frank M. Brunkhorst, Prof. principal investigator
Center for Clinical Studies at Jena University Hospital
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Need of Cardiac Surgery, run by Jena University Hospital at 19 sites in 3 countries.
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 3 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: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Austria, Hungary. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention (time frame: days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02312024, which also lists 3 linked publications.
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 23 Oct 2024.