International Registry on the Use of the CytoSorb Adsorber (CytoSorb)

• ClinicalTrials.gov Identifier: NCT02312024
• Recruitment Status: Unknown
• First Posted: December 9, 2014
• Last Update Posted: December 16, 2019
• Sponsor: Jena University Hospital
• Collaborator: University Hospital Goettingen
• Information provided by (Responsible Party): Jena University Hospital

Tracking Information

• First Submitted Date: December 4, 2014
• First Posted Date: December 9, 2014
• Last Update Posted Date: December 16, 2019
• Study Start Date: January 2015
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 21, 2015): Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: days ]
• Original Primary Outcome Measures (submitted: December 4, 2014): Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention [ Time Frame: 30 days ]

Current Secondary Outcome Measures (submitted: August 21, 2015)

• - 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 ]

Original Secondary Outcome Measures (submitted: December 4, 2014)

• - Organ function (SOFA - score-difference) [ Time Frame: 30 days ]
• - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin [ Time Frame: 30 days ]
• - Length of hospital and ICU stay (days) [ Time Frame: 30 days ]
• - Duration of mechanical ventilation (days) [ Time Frame: 30 days ]
• - Duration of renal replacement therapy (days) [ Time Frame: 30 days ]
• - Duration of vasopressor therapy (days) [ Time Frame: 30 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: International Registry on the Use of the CytoSorb Adsorber
• Official Title: International Registry on the Use of the CytoSorb®-Adsorber in ICU Patients
• Brief Summary: 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 30 Days
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients undergoing treatment with the CytoSorb® adsorber

Condition

• Sepsis
• Need of Cardiac Surgery

Intervention

Device: Use of CytoSorb adsorber

Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.

Study Groups/Cohorts

• Patients with severe sepsis/septic shock
  Use of CytoSorb adsorber in patients with severe sepsis/septic shock
  Intervention: 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
  Intervention: Device: Use of CytoSorb adsorber

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.
• Schittek 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.
• Friesecke 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: December 4, 2014): 3000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Use of the CytoSorb® adsorber
• Age ≥ 18 years
• Signed informed consent

Exclusion Criteria:

- none

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Germany, Hungary

Administrative Information

• NCT Number: NCT02312024
• Other Study ID Numbers: JenaUH
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jena University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Jena University Hospital
• Original Study Sponsor: Same as current
• Collaborators: University Hospital Goettingen

Investigators

• Principal Investigator: Frank M. Brunkhorst, Prof.; Center for Clinical Studies at Jena University Hospital

• PRS Account: Jena University Hospital
• Verification Date: December 2019