Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor α serum levels in cardiac surgery: a randomized controlled trial

Garau, Ingo; März, Alexander; Sehner, Susanne; Reuter, Daniel A.; Reichenspurner, Hermann; Zöllner, Christian; Kubitz, Jens C.

doi:10.23736/s0375-9393.18.12898-7

Cited by 42 publications

(54 citation statements)

References 14 publications

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“…Recently published data of Garau et al [22] also showed minor and short lasting, but a significant reduction in proinflammatory cytokine levels of IL-8 and TNFα in cardiac surgery patients treated with hemadsorption.…”

Section: Discussionmentioning

confidence: 89%

“…Encouraged by promising data from the use of hemadsorption in septic patients, recently the use of this therapeutic method has been expanded to cardiac surgery for reducing systemic inflammation after CPB. However, the first published data, both retrospective and prospective, have been confusing, with reports of both important alleviation [21,22] of inflammation and no significant benefits [23].…”

Section: Introductionmentioning

confidence: 99%

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Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Stupica

Šoštarič

Bozhinovska

et al. 2020

Cardiovascular Therapeutics

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Extracorporeal hemadsorption may reduce inflammatory reaction in cardiopulmonary bypass (CPB) surgery. Glucocorticoids have been used during open-heart surgery for alleviation of systemic inflammation after CPB. We compared intraoperative hemadsorption and methylprednisolone, with usual care, during complex cardiac surgery on CPB, for inflammatory responses, hemodynamics, and perioperative course. Seventy-six patients with prolonged CPB were recruited and randomized, with 60 included in final analysis. Allocation was into three groups: Methylprednisolone (n = 20), Cytosorb (n = 20), and Control group (usual care, n = 20). Proinflammatory (TNF-α, IL-1β, IL-6, and IL-8) and anti-inflammatory (IL-10) cytokines which complement C5a, CD64, and CD163 expression by immune cells were analyzed within the first five postoperative days, in addition to hemodynamic and clinical outcome parameters. Methylprednisolone group, compared to Cytosorb and Control had significantly lower levels of TNF-α (until the end of surgery, p<0.001), IL-6 (until 48 h after surgery, p<0.001), and IL-8 (until 24 h after surgery, p<0.016). CD64 expression on monocytes was the highest in the Cytosorb group and lasted until the 5th postoperative day (p<0.016). IL-10 concentration (until the end of surgery) and CD163 expression on monocytes (until 48 h after surgery) were the highest in the Methylprednisolone group (p<0.016, for all measurements between three groups). No differences between groups in the cardiac index or clinical outcome parameters were found. Methylprednisolone more effectively ameliorates inflammatory responses after CPB surgery compared to hemadsorption and usual care. Hemadsorption compared with usual care causes higher prolonged expression of CD64 on monocytes but short lasting expression of CD163 on granulocytes. Hemadsorption with CytoSorb® was safe and well tolerated. This trial is registered with clinicaltrials.gov (NCT02666703).

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 99%

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Stupica

Šoštarič

Bozhinovska

et al. 2020

Cardiovascular Therapeutics

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“…A growing body of evidence provides reasonable proof that cytokine adsorption using the CytoSorb hemoadsorber results in the effective removal of cytokines, both in vitro 9,10 and in vivo. 6,11 In addition, the removal spectrum Table 1 (median with IQR). The data shown refer to the respective treatment number, that is, data for treatment 1 include all 23 patients, data for treatment 2 include 12 patients, and data for treatment 3 include 9 patients (11 patients with 1 treatment, 3 patients with 2 consecutive treatments, 9 patients with 3 consecutive treatments).…”

Section: Discussionmentioning

confidence: 99%

“…A growing body of evidence provides reasonable proof that cytokine adsorption using the CytoSorb hemoadsorber results in the effective removal of cytokines, both in vitro 9,10 and in vivo. 6,11 In addition, the removal spectrum of CytoSorb also seems to encompass other inflammation-related trigger substances such as pathogen-associated molecular patterns (PAMPs) or damage-associated molecular patterns (DAMPs), substances that can provoke and maintain a generalized inflammatory host response. 12…”

Section: Discussionmentioning

confidence: 99%

Hemoadsorption treatment with CytoSorb^® in patients with extracorporeal life support therapy: A case series

et al. 2019

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Introduction: Extracorporeal life support is an increasingly used technique for respiratory and cardiocirculatory support. Besides primary organ dysfunction, an excessive systemic hyperinflammatory response can be the underlying cause for acute organ failure necessitating extracorporeal life support therapy, or it may be associated with the extracorporeal life support itself. Controlling this overwhelming inflammatory response using CytoSorb® hemoadsorption has been shown to be associated with improved hemodynamics and restored metabolic balance resulting in preserved organ functions. Methods: In this retrospective case series, we describe 23 patients undergoing extracorporeal life support therapy and CytoSorb hemoadsorption. Cytokine levels were monitored, hemodynamic and metabolic variables were recorded, and outcome measures such as duration of organ support, intensive care unit mortality, and hospital mortality were noted. Results: CytoSorb treatment was associated with a trend toward a reduction in plasma cytokine levels (first treatment median interleukin-6 pre 595 vs post 350 pg/mL (n.s.); second treatment median interleukin-6 317 vs 108 pg/mL, p < 0.05), a reduced vasoplegic response resulting in a reduction in vasopressor requirements (first treatment median norepinephrine pre 0.15 vs post 0.02 µg/kg/min (n.s.); second treatment median norepinephrine 0.1 vs 0.02 µg/kg/min, p < 0.05) as well as rebalancing of deranged metabolic parameters (first treatment median lactate pre-treatment 6 vs post-treatment median lactate 2 mmol/L, p < 0.05). The hemoperfusion treatment was well tolerated and safe, without the occurrence of any CytoSorb device-related adverse events. Conclusion: Hemoadsorption may offer a potentially promising therapeutic option for critically ill patients undergoing extracorporeal life support therapy, with cytokine reduction and a consecutively mitigated inflammatory response, decreased vasoplegia, and improved organ function as seen in our patients.

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“…Demgegenüber finden sich zur CytoSorb-Technologie, bei ähnlich lang bestehender CE-Zulassung, diverse Arbeiten aus einer Vielzahl von Zentren, die in Peer-review-Journalen veröffentlicht wurden [ 4 , 5 , 8 – 11 , 13 , 14 , 18 , 19 , 21 – 24 ]. Darüber hinaus findet man im bekannten Register für klinische Studien (Clinicaltrials.gov) mit Stand Januar 2020 insgesamt 33 Projekte zur CytoSorb-Technologie und 3 zur Jafron-Technologie, wobei in den gelisteten Studien mit dem HA-330 als Hauptindikation die Behandlung von chronischem Nierenversagen und nicht der Einsatz in der Intensivmedizin ausgewiesen ist.…”

Section: Aktuelle Wissenschaftliche Datenlageunclassified

Hämoadsorption zur Blutreinigung – Unvergleichbarkeit der klinisch angebotenen Verfahren

Krenn

Steltzer

2020

Med Klin Intensivmed Notfmed

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Zusammenfassung Hintergrund Im Bereich der Intensivmedizin, aber auch verstärkt in der Herzchirurgie, gewinnt der Einsatz von adsorptiven Blutreinigungstechnologien zur Behandlung von hyperinflammatorischen Zuständen an Bedeutung. Neben dem CytoSorb-Verfahren, das zunehmend klinisch akzeptiert und auch aktuell am häufigsten eingesetzt wird, drängen seit Kurzem weitere Firmen – vor allem aus China – mit ähnlichen Konzepten auf den Markt. Ziel der Arbeit Vor diesem Hintergrund soll es Ziel dieses Artikels sein, exemplarisch auf unterschiedliche Aspekte zwischen den am Markt angebotenen Hämoadsorptionsprodukten einzugehen und einen kritischen Blick auf die vorhandene Evidenz zu werfen. Methoden Analysiert wurden technische Merkmale, applikationsspezifische Besonderheiten und vorhandene Evidenz der Adsorptionstechnologien CytoSorb® (CytoSorbentsTM Inc., Monmouth Junction, NJ, USA), Jafron® HA-Serie (Jafron Biomedical Co., Guangdong, China) sowie der Biosky® MG-Serie (Biosun® Medical Technology Co., Foshan City, Guangdong Province, China). Nicht einbezogen wurden rein substanzspezifische Verfahren zur Endotoxinelimination (Toraymyxin®, Alteco®). Ergebnisse Bei umfassender Analyse dieser Kriterien zeigt sich, dass zwischen den verfügbaren Technologien erhebliche Unterschiede hinsichtlich verwendeter Materialien, Adsorptionscharakteristika, Anwendung und verfügbarer Daten zu Sicherheit und klinischer Erfahrungen bestehen. Darüber hinaus wird deutlich, dass bei Blutreinigungstechnologien nicht nur deren Wirksamkeit unter Berücksichtigung eines Effekt-Preis-Leistungs-Verhältnisses betrachtet werden sollte, sondern insbesondere auch die klinische Sicherheit der einzelnen Verfahren von entscheidender Bedeutung ist. Diskussion Unter den analysierten Technologien stellt unserer Ansicht nach derzeit CytoSorb das am besten untersuchte und klinisch am weitesten etablierte Verfahren dar. Darüber hinaus ist darauf hinzuweisen, dass klinische Ergebnisse, insbesondere jedoch auch sicherheitsrelevante Aspekte, aufgrund der technisch unterschiedlichen Verfahren nicht zwischen den Produkten übertragbar sind.

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Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor α serum levels in cardiac surgery: a randomized controlled trial

Cited by 42 publications

References 14 publications

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Hemoadsorption treatment with CytoSorb^® in patients with extracorporeal life support therapy: A case series

Hämoadsorption zur Blutreinigung – Unvergleichbarkeit der klinisch angebotenen Verfahren

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Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor α serum levels in cardiac surgery: a randomized controlled trial

Cited by 42 publications

References 14 publications

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Extracorporeal Hemadsorption versus Glucocorticoids during Cardiopulmonary Bypass: A Prospective, Randomized, Controlled Trial

Hemoadsorption treatment with CytoSorb® in patients with extracorporeal life support therapy: A case series

Hämoadsorption zur Blutreinigung – Unvergleichbarkeit der klinisch angebotenen Verfahren

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Hemoadsorption treatment with CytoSorb^® in patients with extracorporeal life support therapy: A case series