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International Registry on the Use of the CytoSorb Adsorber (CytoSorb)
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| First Received Date ICMJE | December 4, 2014 | ||||||||
| Last Updated Date | June 3, 2016 | ||||||||
| Start Date ICMJE | January 2015 | ||||||||
| Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ICMJE |
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 ] | ||||||||
| Change History | Complete list of historical versions of study NCT02312024 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | International Registry on the Use of the CytoSorb Adsorber | ||||||||
| Official Title ICMJE | 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. |
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| Study Type ICMJE | Observational [Patient Registry] | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | 30 Days | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients undergoing treatment with the CytoSorb® adsorber | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 3000 | ||||||||
| Estimated Completion Date | December 2020 | ||||||||
| Estimated Primary Completion Date | December 2017 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - none |
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Senior) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Austria, Germany, Hungary | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT02312024 | ||||||||
| Other Study ID Numbers ICMJE | JenaUH | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product | Not Provided | ||||||||
| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Jena University Hospital | ||||||||
| Study Sponsor ICMJE | Jena University Hospital | ||||||||
| Collaborators ICMJE | University Hospital Goettingen | ||||||||
| Investigators ICMJE |
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| PRS Account | Jena University Hospital | ||||||||
| Verification Date | June 2016 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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