NCT02312024

Brief Summary

Registry on the use of the CytoSorb® adsorber in ICU patients.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,434

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
3 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 9, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
Last Updated

October 23, 2024

Status Verified

December 1, 2019

Enrollment Period

6.1 years

First QC Date

December 4, 2014

Last Update Submit

October 21, 2024

Conditions

Keywords

CytoSorb adsorbersepsiscytokineshemofiltrationhemadsorptioninflammation

Outcome Measures

Primary Outcomes (1)

  • Difference between mortality predicted by scoring systems (APACHE II/SAPS II, EuroSCORE II) and actual mortality within 30 days after intervention

    days

Secondary Outcomes (6)

  • - Organ function (SOFA - score-difference)

    days

  • - Concentration of biomarkers IL-6, CRP, PCT, myoglobin, free hemoglobin

    days

  • - Length of hospital and ICU stay (days)

    days

  • - Duration of mechanical ventilation (days)

    days

  • - Duration of renal replacement therapy (days)

    days

  • +1 more secondary outcomes

Study Arms (4)

Patients with severe sepsis/septic shock

Use of CytoSorb adsorber in patients with severe sepsis/septic shock

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

Device: Use of CytoSorb adsorber

Interventions

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

Patients with other indicationsPatients with severe sepsis/septic shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing treatment with the CytoSorb® adsorber

You may qualify if:

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

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Krankenhaus Hietzing

Vienna, Austria

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Evangelisches Krankenhaus

Bielefeld, Germany

Location

Carl-Thiem-Klinikum

Cottbus, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Klinikum Emden

Emden, Germany

Location

Kliniken Erlabrunn gGmbH

Erlabrunn, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Greifswald University Hospital

Greifswald, Germany

Location

Krankenhaus St. Elisabeth & St. Barbara

Halle, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Krankenhaus Herzberg, Elbe-Elster-Klinikum GmbH

Herzberg, Germany

Location

Kliniken Maria Hilf GmbH Mönchengladbach

Mönchengladbach, Germany

Location

Klinikum rechts der Isar der TU München

München, Germany

Location

Klinikum Oldenburg

Oldenburg, Germany

Location

University Hospital Ulm

Ulm, Germany

Location

Kliniken Nordoberpfalz AG, Klinikum Weiden

Weiden, Germany

Location

University of Szeged

Szeged, Hungary

Location

Related Publications (3)

  • 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.

    PMID: 36282800BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

SepsisInflammation

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Frank M. Brunkhorst, Prof.

    Center for Clinical Studies at Jena University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2014

First Posted

December 9, 2014

Study Start

January 1, 2015

Primary Completion

February 4, 2021

Study Completion

February 4, 2021

Last Updated

October 23, 2024

Record last verified: 2019-12

Locations