TABLE 1.
Trial | Country | Design | N | Population | CytoSorb® regimen | Control | Latest follow‐up |
---|---|---|---|---|---|---|---|
Published trials | |||||||
Asch 2021 37 | Germany | Single‐center | 20 | Infective endocarditis undergoing cardiac surgery | CytoSorb® incorporated in the CPB circuit. Postoperatively, integrated in a hemodialysis circuit. Treatment duration: CPB time + 24 h (cartridge change every 8 h, 4 in total). | Conventional therapy (CPB without CytoSorb®) | In‐hospital |
Bernardi 2016 35 | Austria | Single‐center | 37 | Elective CABG, valve surgery, or combined procedure with an expected CPB duration of more than 2 h | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 30 days |
Diab 2022 39 | Germany | Multi‐center | 202 | Cardiac surgery for infective endocarditis | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 30 days |
Garau 2019 31 | Germany | Single‐center | 40 | Elective CABG, AVR, or a combined procedure with an expected CPB time of more than 2 h | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | — |
Gleason 2019 32 | USA | Multi‐center | 46 | Elective complex cardiac surgery with expected CPB duration equal or longer than 3 h | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 30 days |
Hawchar 2019 29 | Hungary | Single‐center | 20 | Intubated patients with suspected septic shock of medical origin | CytoSorb® incorporated in a blood pump circuit using a renal replacement device. Anticoagulation: heparin. Hemodialysis catheter inserted into a central vein. Treatment duration: 24 h. | Conventional therapy | Unclear |
Holmén 2022 45 | Sweden | Single‐center | 19 | Cardiac surgery for infective endocarditis | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | — |
Poli 2019 30 | Switzerland | Single‐center | 30 | Elective cardiac surgery with expected long CPB duration and deemed at high risk of postoperative complications | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | In‐hospital |
Schädler 2017 19 | Germany | Multi‐center | 97 | Severe sepsis or septic shock a in the setting of acute lung injury or ARDS | CytoSorb® either used alone in hemoperfusion mode or incorporated in the CCVH/CVVHD circuit if renal replacement therapy was indicated. Anticoagulation: systemic heparin or regional citrate. Treatment duration: 6 h per day, up to 7 consecutive days | Conventional therapy | 60‐days |
Stockmann 2022 38 | Germany | Single‐center | 49 | COVID‐19 associated vasoplegic shock requiring norepinephrine, elevated C‐reactive protein, and indication for kidney replacement therapy | CytoSorb incorporated in the CVVHD circuit and replaced every 24 h. Treatment duration: 3–7 days according to the discretion of the treating physicians. | Conventional therapy (CVVHD without CytoSorb®) |
ICU mortality |
Supady 2021 20 | Germany | Single‐center | 34 | Severe ARDS related to SARS‐CoV‐2 infection receiving venovenous ECMO | CytoSorb® incorporated into the ECMO circuit. Treatment duration: 72 h (cartridge change every 24 h). | Conventional therapy (ECMO without CytoSorb®) | 90 days |
Supady 2022 21 | Germany | Single‐center | 41 | Extracorporeal cardiopulmonary resuscitation | CytoSorb incorporated into the ECMO circuit and replaced every 24 h. Treatment duration: 72 h. | Conventional therapy (ECMO without CytoSorb®) | 30 days |
Taleska Stupica 2020 34 | Slovenia | Single‐center | 40 | Elective complex cardiac surgery with an expected CPB time of more than 1.5 h | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 1 year |
Wagner 2019 33 | Czech Republic | Single‐center | 28 | Complex cardiac surgery (Ross operation 93%, David operation 7%) | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 3 months |
Unpublished trials | |||||||
NCT03145441 (ongoing) 41 | Hungary | Single‐center | 51 | Heart transplantation without any medical or mechanical circulatory support, sepsis, acute kidney or liver injury, or prolonged hospitalization before transplantation | CytoSorb® incorporated in the CPB circuit | Conventional therapy (CPB without CytoSorb®) | 30 days |
NCT03523039 (ongoing) 40 | Switzerland | Single‐center | 21 | Post‐cardiac arrest syndrome (need for a vasoconstrictor, elevated serum lactate) and time to return of spontaneous circulation higher than 25 minutes |
CytoSorb® integrated in a hemoperfusion circuit. Anticoagulation: regional heparin‐protamine. Treatment duration: 12 to 24 h |
Conventional therapy | ICU mortality |
NCT04361526 (stopped) 42 | Spain | Single‐center | 2 | Acute onset of moderate to severe COVID‐19 ARDS needing ventilation support | CytoSorb® integrated in a hemoperfusion circuit. Anticoagulation: systemic heparin. Hemodialysis catheter inserted in a central vein. Treatment duration: 72 h (cartridge change every 24 h) | Conventional therapy | NR |
NCT04518969 (ongoing) 43 | Belgium | Single‐center | 9 | COVID‐19 ARDS needing intubation | CytoSorb® integrated in a CVVHD circuit. Treatment duration: 4 days (cartridge change: two changes after 12 h, every 24 h after) |
Conventional therapy |
NR |
Abbreviations: ARDS, acute respiratory distress syndrome; CABG, coronary artery bypass graft; CPB, cardiopulmonary bypass; CVVHD, continuous veno‐venous hemodialysis; ECMO, extracorporeal membrane oxygenation.