Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial

Poli, Elettra; Alberio, Lorenzo; Bauer-Doerries, Anna; Marcucci, Carlo; Roumy, Aurélien; Kirsch, Matthias; Stefano, Eleonora de; Liaudet, Lucas; Schneider, Antoine

doi:10.1186/s13054-019-2399-4

Cited by 98 publications

(131 citation statements)

References 20 publications

(22 reference statements)

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“…e results of our trial are supported by two prospective randomized clinical trials, by Bernardi et al [23] (on 37 patients, 18 with hemadsorption) and by Poli et al [25] (on 30 patients, 15 with hemadsorption). Both showed no effects of hemadsorption with Cytosorb ® during CPB, neither on 'biochemical alleviation' of post-CPB SIRS, nor on patient clinical outcomes.…”

Section: Discussionsupporting

confidence: 73%

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: Discussionsupporting

confidence: 73%

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

Stupica

Šoštarič

Bozhinovska

et al. 2020

Cardiovascular Therapeutics

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“…The case series comparing intraoperative vs. intraoperative and postoperative use of Cytosorb showed that more intense therapy (intra-operative and post-operative) might be associated with patient improvement [27]. However, two prospective, randomized, blind and controlled trials did not confirm the previous results [28,29]. There was no significant difference in inflammatory markers, blood substitution, vasopressor need or mortality.…”

Section: State Of Knowledgementioning

confidence: 94%

Applications of Cytosorb in clinical practice

Kutnik¹,

Borys²

2019

J Pre Clin Clin Res.

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Introduction and objective. Cytososorb is haemadsorption device approved in the European Union in 2011 for cytokine adsorption. Recently, in 2018, new indications for the device use have been added, including bilirubin and myoglobin removal. This study aimed to present the results of studies pertaining to Cytosorb use in clinical practice. In subsequent sections of this review, indications for Cytosorb therapy and clinical relevance of presented evidence are listed. State of knowledge. In clinical practice, Cytosorb has been reported as one of potential supportive therapies in patients with septic shock. There is evidence of significant reduction of interleukin 6 and vasopressors when Cytosorb is implemented. However, the decreased mortality after Cytosorb has yet to be reported. Besides cytokine adsorption, Cytosorb also collects drugs, a property that can have a beneficial effect on acute drug poisoning (anticoagulants). However, Cytosorb lowers the plasma concentration of some antibiotics which might affect the outcome of patients in septic shock. The haemadsorption device has also been researched in cardiac patients, and some reports suggest a reduced need for vasopressors and blood transfusions when therapy is installed during surgery. Other indications for Cytosorb are also reported, especially the effectiveness in decreasing bilirubin serum concentrations as treatment or bridge therapy, without affecting the albumins. Cytosorb might also be the last resort treatment in acquired haemophagocytic lymphohistiocytosis. Conclusions. The evidence supporting the use of CytoSorb remains elusive. There is lack of large prospective studies which could provide definitive answers about the place of Cytosorb in clinical practice. There are no reports of safety and feasibility issues in all presented studies.

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“…The listed exclusion criteria are set to minimize the impact of perioperative variables, which may potentially undermine the validity of the study. The exclusion criteria are also backed up by a number of studies focusing on cardiac surgery [ 13 – 15 ].…”

Section: Methodsmentioning

confidence: 99%

Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial

Yang

Zhu

et al. 2020

Trials

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Background Cardiopulmonary bypass (CPB) is an important cause of significant systemic inflammatory response syndrome (SIRS) in the surgical treatment of acute type A aortic dissection (ATAAD). In patients with arch vessel involvement, extensive surgical repairs often necessitate prolonged use of CPB and results in extensive inflammatory responses. Cytokines and chemokines released during CPB contribute to the progression of SIRS, increase perioperative complications, and negatively impact surgical outcomes. A cytokine adsorber (HA380) is expected to reduce the level of cytokines during CPB, which may decrease both intraoperative and postoperative inflammation. The purpose of this study is to investigate if HA380 is able to reduce the levels of inflammatory cytokines and decrease perioperative complications in ATAAD patients undergoing CPB and deep hypothermic circulatory arrest (DHCA). Methods This study is a single-center, randomized, controlled, double-blind clinical trial. The study aims to recruit 88 patients with ATAAD and aortic arch involvement who will undergo CPB and DHCA to repair the dissected aorta. Patients will be randomized equally into the CPB/DHCA only group (control group) and the CPB/DHCA + HA380 hemoperfusion group (intervention group), with 44 patients each. Patients in the control group will undergo CPB and DHCA only, while patients in the intervention group will undergo continuous hemoperfusion with HA380, in addition to CPB and DHCA. The primary outcome is a composite of major perioperative complications. The secondary outcomes include related inflammatory markers, coagulation parameters, and minor perioperative complications. To comprehensively evaluate the effect of hemoperfusion on the perioperative outcomes, we will also determine if there are differences in perioperative all-cause mortality, length of ICU stay, and total hospitalization costs. Discussion In the current trial, hemoperfusion will be applied in patients undergoing CPB and DHCA for repair of the aorta involving the aortic arch. This trial aims to test the safety and efficacy of our hemoperfusion device (HA380) in such settings. Upon completion of the trial, we will determine if HA380 is effective in reducing perioperative proinflammatory cytokine levels. Further, we will also verify if reduction in the proinflammatory cytokine levels, if present, translates to improvement in patient outcomes. Trial registration ClinicalTrials.gov NCT04007484. Registered on 1 July 2019 (retrospectively registered).

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Cytokine clearance with CytoSorb® during cardiac surgery: a pilot randomized controlled trial

Cited by 98 publications

References 20 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

Applications of Cytosorb in clinical practice

Hemoperfusion with HA380 in acute type A aortic dissection patients undergoing aortic arch operation (HPAO): a randomized, controlled, double-blind clinical trial

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