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Therapeutic effects

Removal of inflammatory mediators

(Cytokines, chemokines, anaphylatoxins etc.)

The main focus of CytoSorb therapy is the removal of inflammatory mediators, especially cytokines and chemokines, from the patient’s blood. With the CytoSorb adsorber not single defined cytokines are removed, but a broad spectrum of pro- and anti-inflammatory mediators. This is of particular importance since different messenger substances cause in part redundant effects and previous attempts to reduce individual substances have not proved to be successful.

Decisive in the removal by the adsorber is the concentration of mediators in the blood. At high concentrations, large quantities can be removed very quickly; with decreasing concentration, the removal rate decreases. At low concentrations, clearance drops to near zero. This autoregulation based on physicochemical mechanisms protects against complete, nonphysiological removal of the cytokines. Furthermore, the anaphylatoxin C3a and C5a are significantly removed as a highly potent inflammatory mediator and also procalcitonin. (Ref: 1-10)

Removal of other endogenous molecules

(Myoglobin, free hemoglobin, bilirubin, bile acids)

In addition to the removal of cytokines, the removal of substances that play an important role outside the systemic inflammation in the pathophysiology of certain critical diseases has also been identified. These include:

Myoglobin: Acute renal failure secondary to rhabdomyolysis is the main reason for the desire to rapidly reduce high levels of myoglobin in the patient’s blood. Rhabdomyolysis, a disintegration of muscle fibers with subsequent flooding of muscle proteins and cell components, can occur in trauma, burns, infections or muscle overuse. The 17 kD molecule myoglobin can be effectively removed from the blood using CytoSorb. (Ref: 11-12)

Free hemoglobin: Free hemoglobin, like free iron, is toxic. Hemoglobin released by hemolysis is normally bound to haptoglobin and then degraded. With increasing hemolysis, the binding capacity of haptoglobin is exhausted. Freeing hemoglobin can then no longer be bound and occurs freely in the plasma. Hemolyses can be triggered by mechanical influences (ECMO, HLM), infections / toxins (malaria, streptococci, EHEC), immune reactions (rhesus incompatibility) or other causes. Substantial removal of the substance from the patient’s blood can be achieved with CytoSorb. (Ref: 9)

Bilirubin: Bilirubin and biliverdin are breakdown products of hemoglobin and are massively increased in the blood, if a disproportionate amount of hemoglobin is broken down by haemolysis or if accumulation of blood occurs in the blood due to a liver function or dissolution disorder (cholestasis). Various publications have shown excellent removability of bilirubin (0.6 kDa) by CytoSorb. (Ref: 13)

Bile Acids: Bile acids, or their accumulation in plasma, play a significant, previously often underestimated role in critical diseases, e.g. Sepsis, systemic inflammation and liver failure. With CytoSorb high levels can be lowered quickly and thus prevent toxic effects. (Ref: 14)

Removal of exogenous molecules

(Bacteria toxins – enterotoxins, metals, drugs and substances with high protein binding)

Enterotoxins: Enterotoxins are secreted by bacteria in the gut and can cause serious disease symptoms (e.g., Shigella toxin, EHEC toxin). Enterotoxins can also be used as biological weapons. It has been shown that CytoSorb quickly and safely removes a number of these toxins from the blood. (Ref: 15)

Metals: The ability to effectively remove metals from the blood, e.g. Iron, copper or mercury is suspected, but still has to be systematically investigated.

Medicines: Substances which are either intended to replace naturally occurring substances in the human body because of a deficiency, or which are to induce certain effects on account of their chemical properties, are subject to the same physical laws of transport, metabolization and excretion as endogenous substances. Like other extracorporeal blood purification methods, e.g. Dialysis or hemofiltration, CytoSorb also interacts with both endogenous and exogenous molecules in the blood. The influence of CytoSorb on certain drugs should be considered when dosing and ensuring drug therapies. This can also be used to advantage in certain drugs for the removal of undesirably high plasma levels due to overdose or intoxication.

In this context, successful therapeutic trials for venlaflaxin overdoses are published. In addition, in patients who need to undergo emergency intervention while receiving treatment with platelet inhibitors or NOAKs, the intraoperative removal of the substance by CytoSorb u.U. Bleeding complications are reduced. (Ref: 16-20)


 
References
 
Removal of inflammatory mediators
 
(1) Treatment of post-cardiopulmonary bypass SIRS by hemoadsorption: a case series
Trager K, Fritzler D, Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Int J Artif Organs 2016; 39(3): 141-146
 
(2) Systemic Inflammatory Response Syndrome in der Herzchirurgie: Neue Therapiemöglichkeiten durch den Einsatz eines Cytokin-Adsorbers während EKZ?
Born F, Pichlmaier M, Peterß S, Khaladj N, Hagl C
Kardiotechnik 2/2014
 
(3) Modulation of chemokine gradients by apheresis redirects leukocyte trafficking to different compartments during sepsis, studies in a rat model.
Peng ZY, Bishop JV, Wen XY, Elder MM, Zhou F, Chuasuwan A, Carter MJ, Devlin JE, Kaynar AM, Singbartl K, Pike F, Parker RS, Clermont G, Federspiel WJ, Kellum JA.
Crit Care. 2014 Jul 3;18(4):R141
 
(4) The effect of a novel extracorporeal cytokine hemoadsorption device on IL-6 elimination in septic patients: A randomized controlled trial
Schaedler D, Pausch C, Heise D, Meier-Hellmann A, Brederlau J, Weiler N, Marx G, Putensen C, Spies C, Jorres A, Quintel M, Engel C, Kellum JA, Kuhlmann MK
PLoS One 2017; 12(10): e0187015
 
(5) Hemoadsorption Reprograms Inflammation in Experimental Gram-Negative Septic Peritonitis: Insights from In Vivo and In Silico Studies.
Namas RA, Namas R, Lagoa C, Barclay D, Mi Q, Zamora R, Peng Z, Wen X, Fedorchak MV, Valenti IE, Federspiel WJ, Kellum JA, Vodovotz Y
Mol Med. 2012 Dec 20;18:1366-74
 
(6) Effects of hemoadsorption on cytokine removal and short-term survival in septic rats
Peng X, Carter M, Kellum J.A.
Crit Care Med. 2008 May;36(5):1573-7
 
(7) Feasibility study of cytokine removal by hemoadsorption in brain-dead humans
Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M
Crit Care Med. 2008 Jan;36(1):268-72
 
(8) Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-кB DNA binding, and improves short-term survival in lethal endotoxemia
Kellum JA, Song M, Venkataraman R
Crit Care Med. 2004 Mar;32(3):801-5
 
(9) Hemoadsorption to Reduce Plasma Free Hemoglobin during Cardiac Surgery: Results of REFRESH I Pilot Study
Gleason TG, Argenziano M, Bavaria JE, Kane LC, Coselli JS, Engelman RM, Tanaka KA, Awad A, Sekela ME, Zwischenberger JB.
Semin Thorac Cardiovasc Surg 2019; epub
 
(10) Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study
Hawchar F, László I, Öveges N, Trásy D, Ondrik Z, Molnar Z
Journal of Critical Care 2019; 49:172-178
 
Removal of other endogenous molecules
 
  • Myoglobin
 
(11) Cytosorb™ in a patient with legionella-pneumonia associated rhabdomyolysis
Wiegele M, Krenn CG.
ASAIO J. 2015; 61 (3): e14-6
 
(12) In-Vitro Myoglobin Clearance by a Novel Sorbent System
Viktoriya I. Kuntsevich, Donald A. Feinfeld, Pat F. Audia, Wendell Young, Vincent Capponi, Marianna Markella and James F. Winchester
Artificial Cells, Blood Substitutes, and Biotechnology. 2009;37:45-47
 
  • Bilirubin
(13) Removal of Bilirubin with a New Adsorbent System: In Vitro Kinetics.
Gemelli C, Cuoghi A, Magnani S, Atti M, Ricci D, Siniscalchi A, Mancini E, Faenza S.
Blood Purif 2019; 47(1):10-15
 
  • Bile acids
(14) Removal of bile acids by extracorporeal therapies: an in vitro study
Hartmann J and Harm S
Int J Artif Organs 2017; 40(1): 4 – 8
 
Removal of exogenous molecules – enterotoxins
 
(15) Broad adsorption of sepsis-related PAMP and DAMP molecules, mycotoxins, and cytokines from whole blood using CytoSorb(R) sorbent porous polymer beads
Gruda MC, Ruggeberg KG, O’Sullivan P, Guliashvili T, Scheirer AR, Golobish TD, Capponi VJ, Chan PP
PLoS One 2018; 13(1): e0191676
 
Removal of exogenous molecules – drugs
 
(16) Ticagrelor Removal From Human Blood
Angheloiu GO, Gugiu GB, Ruse C, Pandey R, Dasari RR, Whatling C,
JACC: Basic to Translational Science 2017;2(2):135–145
 
(17) Extracorporeal Hemoperfusion as a Potential Therapeutic Option for Critical Accumulation of Rivaoxaban
Koertge A, Wasserkort R, Wild T, Mitzner S.
Blood Purification 2018; 45: 126 – 8
 
(18) Cytosorb adsorption during emergency cardiac operations in patients at high risk of bleeding
Hassan K, Kannmacher J, Wohlmuth P, Budde U, Schmoeckel M, Geidel S
Annals of Thoracic Surgery 2019; 108(1); 45 – 51
 
(19) Venlafaxine intoxication with development of takotsubo cardiomyopathy: successful use of extracorporeal life support, intravenous lipid emulsion and CytoSorb
Schroeder I, Zoller M, Angstwurm M, Kur F, Frey L
Int J Artif Organs, 2017;40(7):358-60
 
(20) First-in-Man Fully Percutaneous Complete Bypass of Heart and Lung
Napp LC, Vogel-Claussen J, Schäfer A, Haverich A, Bauersachs J, Kühn C, Tongers J.
JACC Cardiovasc Interv 2017; 10(24): e231 – 3

Attenuation of the excessive acute phase reaction

The acute phase reaction is a nonspecific immune response of the body and part of the inflammatory response. An excessive acute phase response is associated with a number of potential complications.

These relate in particular to coagulation and microcirculation disorders with consequent deterioration of tissue oxygenation and secondary organ dysfunction due to impaired homeostasis. The attenuation of an excessive acute phase reaction by CytoSorb is intended to normalize coagulation and homeostasis, as well as to reduce overall systemic inflammation. (Ref: 1-5)

 

Reduction of cytokine production

 

The clinical effects of CytoSorb therapy are only partially based on the direct removal of cytokines and chemokines. Several studies have shown that CytoSorb can slow down or stop the production of cytokines by the immune cells in the cytokine storm. On the one hand, this is made possible by the lower plasma levels of pro-inflammatory cytokines, since these can have a self-reinforcing effect on new production; on the other hand, molecules are removed which initiate or sustain the inflammatory cascade. (Ref: 5-9)

References

Attenuation of the excess acute phase reaction

(1) Treatment of post-cardiopulmonary bypass SIRS by hemoadsorption: a case series
Trager K, Fritzler D, Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Int J Artif Organs 2016; 39(3): 141-146

(2) Systemic Inflammatory Response Syndrome in der Herzchirurgie: Neue Therapiemöglichkeiten durch den Einsatz eines Cytokin-Adsorbers während EKZ?
Born F, Pichlmaier M, Peterß S, Khaladj N, Hagl C
Kardiotechnik 2/2014

(3) Feasibility study of cytokine removal by hemoadsorption in brain-dead humans
Kellum JA, Venkataraman R, Powner D, Elder M, Hergenroeder G, Carter M
Crit Care Med. 2008 Jan;36(1):268-7

(4) Effects of hemoadsorption on cytokine removal and short-term survival in septic rats
Peng X, Carter M, Kellum J.A.
Crit Care Med. 2008 May;36(5):1573-7

(5) Cytokine and DAMP adsorption in septic acute kidney injury
C.M. Laubach, K.-P. Janssen, W. Johannes, R. Bogdanski, B. Kapfer
Intensive Care Medicine Experimental 2018, 6(Suppl 2):0627

Reduction of cytokine production

(6) Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-кB DNA binding, and improves short-term survival in lethal endotoxemia
Kellum JA, Song M, Venkataraman R
Crit Care Med. 2004 Mar;32(3):801-5

Realignment of activated leukocytes

(7) Modulation of chemokine gradients by apheresis redirects leukocyte trafficking to different compartments during sepsis, studies in a rat model
Peng ZY, Bishop JV, Wen XY, Elder MM, Zhou F, Chuasuwan A, Carter MJ, Devlin JE, Kaynar AM, Singbartl K, Pike F, Parker RS, Clermont G, Federspiel WJ, Kellum JA
Crit Care 2014, 18(4):R141
(8) Hemoadsorption reprograms inflammation in experimental gram-negative septic peritonitis: insights from in vivo and in silico studies.
Namas RA, Namas R, Lagoa C, Barclay D, Mi Q, Zamora R, Peng Z, Wen X, Fedorchak MV, Valenti IE, Federspiel WJ, Kellum JA, Vodovotz, Y.
Mol Med 2012; 18:1366-74.
(9) Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis
Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmelé T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA
Kidney Int. 2012 Feb;81(4):363-9

The clinical effects of using CytoSorb therapy are highly dependent on the indication, the clinical situation and the treatment regimen. The therapy is not to be used as an ultima-ratio treatment, but rather for its positive clinical effects, especially with careful patient selection, timely use and adequate dosing. Existing therapeutic principles, such as focal source removal and early anti-infective therapy in sepsis remain of utmost importance. Goals for the use of CytoSorb therapy are the aimed at the following clinical effects:

Stabilization of hemodynamics (micro- and macro-circulation)

A frequently described and reproducible effect is the stabilization in the macro-hemodynamics associated with a (normally) significant decrease in catecholamine requirements. It seems that the level of cytokines determines the severity of the hemodynamic disorder and the extent of the reduction in the level of the therapeutic effect. Earlier achievement of being free from catecholamines has been observed in patients with septic shock, and is also systematically reviewed in clinical trials. (Ref: 1-11)

Influence on capillary leak

The reduction in systemic peak cytokine levels means that their negative impact on the vascular endothelial integrity also decreases. In preclinical studies, the group led by Dr John Kellum of Pittsburgh (USA) clearly demonstrated this effect, and in vitro measurements on human endothelial cell layers with untreated and treated plasma have tentatively confirmed this. Even previous clinical observations appear to confirm these results. Repairing the systemic capillary leak potentially stops the passage of fluid, proteins, and immune cells into various tissues and prevents the progression of organ damage. At the same time, the regeneration of organ functions may also be promoted by these effects. (Ref: 12-18)

Organ protection and treatment of multi-organ dysfunction

Organ protection can be achieved in different clinical situations and through different mechanisms of action. For example, the consistent reduction of high plasma levels of myoglobin using CytoSorb helps prevent renal insufficiency secondary to rhabdomyolysis. A similar effect is the massive removal of free hemoglobin in cases of significant hemolysis. The removal of potentially cytotoxic substances such as bile acids, supports liver detoxicfication function.

Multi-organ dysfunction or failure (lung, kidney, liver, heart, circulation, etc.) are common complications of severe or excessive systemic inflammatory reactions. Dampening or neutralization of the so-called cytokine storm by the CytoSorb therapy can prevent or mitigate this organ failure. If the organ dysfunction is exclusively the result of inflammation and not due to subsequent onset cell damage, the organ function can also recover by dampening systemic inflammation with CytoSorb. This has already been shown in various preclinical studies; further studies confirming these effects in the clinical setting are currently in progress.

Re-direction of cellular immune defense

A potential additional therapeutic effect is based on influencing the cellular immune response by lowering cytotoxin and chemokine levels in the patient’s blood. This may “unmask” an existing infectious focus, as the local mediator levels remain high despite a reduction in systemic levels. The resulting concentration gradient of the inflammatory mediators between focus and periphery could reorient the previously undirected, systemic cellular immune response to the focus. Dr Peng and coworkers were able to prove this preclinically. Confirmation under clinical conditions is currently being sought. (Ref: 17-18)

 

Prevention or mitigation of excess systemic inflammation under extracorporeal circulation

Study results in cardiac surgery patients show that the use of CytoSorb therapy can prevent or significantly reduce systemic inflammation due to the use of the heart-lung machine (HLM). This has previously been seen in pre-clinical projects. The lack of, or greatly reduced, systemic inflammation then potentially induces no, or less complications, such as hemodynamic instability or secondary organ dysfunction. The clinical data of the above mentioned study are currently being evaluated. (Ref: 19-20)


 

References

Stabilization of hemodynamics (micro and macro circulation)

(1) Treatment of post-cardiopulmonary bypass SIRS by hemoadsorption: a case series
Trager K, Fritzler D, Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Int J Artif Organs 2016; 39(3): 141-146
(2) Combination of ECMO and cytokine adsorption therapy for severe sepsis with cardiogenic shock and ARDS due to Panton-Valentine leukocidin-positive Staphylococcus aureus pneumonia and H1N1
Lees NJ, Rosenberg A, Hurtado-Doce AI, Jones J, Marczin N, Zeriouh M, Weymann A, Sabashnikov A, Simon AR, Popov AF
J Artif Organs 2016 epub
(3) Septic shock secondary to β-hemolytic streptococcus-induced necrotizing fasciitis treated with a novel cytokine adsorption therapy.
Hetz H, Berger R, Recknagel P, Steltzer H.
Int J Artif Organs. 2014 37(5): 422-6
(4) CytoSorb, a novel therapeutic approach for patients with septic shock: a case report
Hinz B, Jauch O, Noky T, Friesecke S, Abel P, Kaiser R
Int J Artif Organs 2014 38(8): 461-46
(5) First description of SPAD combined with cytokine adsorption in fulminant liver failure and hemophagocytic syndrome due to generalized HSV-1 infection.
Frimmel S, Schipper J, Henschel J, Yu TT, Mitzner SR, Koball S.
Liver Transpl. 2014 Dec;20(12):1523-4
(6) Use of a novel hemoadsorption device for cytokine removal as adjuvant therapy in a patient with septic shock with multi-organ dysfunction: A case study
Basu R, Pathak S, Goyal J, Chaudhry R, Goel RB, Barwal A
Indian J Crit Care Med 2014;18:822-4
(7) Effects of a novel cytokine haemoadsorbtion system on inflammatory response in septic shock after cephalic pancreatectomy – a case report
Tomescu D, Dima SO, Tănăsescu S, Tănase CP, Năstase A , Popescu M
Romanian Journal of Anaesthesia and Intensive Care 2014;21(2):134-138
(8) Improvement of hemodynamic and inflammatory parameters by combined hemoadsorption and hemodiafiltration in septic shock: a case report.
Mitzner SR, Gloger M, Henschel J, Koball S
Blood Purif. 2013;35(4):314-5.
(9) Effects of hemoadsorption on cytokine removal and short-term survival in septic rats
Peng ZY, Carter MJ, Kellum JA
Crit Care Med. 2008 May;36(5):1573-7
(10) Hemoadsorption removes tumor necrosis factor, interleukin-6, and interleukin-10, reduces nuclear factor-кB DNA binding, and improves short-term survival in lethal endotoxemia
Kellum JA, Song M, Venkataraman R
Crit Care Med. 2004 Mar;32(3):801-5
(11) Extracorporeal Cytokine Elimination as Rescue Therapy in Refractory Septic Shock – a Prospective Single-Center Study
Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A.
Journal Artif Organs 2017; 20(3): 252-9

Influence on capillary leak

(12) Cytokine Reduction in the Setting of an ARDS-Associated Inflammatory Response with Multiple Organ Failure
Trager K, Schutz C,Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Case Rep Crit Care 2016: 9852073
(13) CytoSorb, a novel therapeutic approach for patients with septic shock: a case report
Hinz B, Jauch O, Noky T, Friesecke S, Abel P, Kaiser R
Int J ArtifOrgans. 2015 Sep 18;38(8):461-4
(14) Modulation of chemokine gradients by apheresis redirects leukocyte trafficking to different compartments during sepsis, studies in a rat model.
Peng ZY, Bishop JV, Wen XY, Elder MM, Zhou F, Chuasuwan A, Carter MJ, Devlin JE, Kaynar AM, Singbartl K, Pike F, Parker RS, Clermont G, Federspiel WJ, Kellum JA.
Crit Care. 2014 Jul 3;18(4):R141
(15) Effect of cytokine hemoadsorption on brain death-induced ventricular dysfunction in a porcine model.
Mikhova KM, Don CW, Laflamme M, Kellum JA, Mulligan MS, Verrier ED, Rabkin DG
J Thorac Cardiovasc Surg. 2013 Jan;145(1):215-24
(16) Hemoadsorption Reprograms Inflammation in Experimental Gram-Negative Septic Peritonitis: Insights from In Vivo and In Silico Studies.
Namas RA, Namas R, Lagoa C, Barclay D, Mi Q, Zamora R, Peng Z, Wen X, Fedorchak MV, Valenti IE, Federspiel WJ, Kellum JA, Vodovotz Y
Mol Med. 2012 Dec 20;18:1366-74
(17) Acute removal of common sepsis mediators does not explain the effects of extracorporeal blood purification in experimental sepsis
Peng ZY, Wang HZ, Carter MJ, Dileo MV, Bishop JV, Zhou FH, Wen XY, Rimmelé T, Singbartl K, Federspiel WJ, Clermont G, Kellum JA
Kidney Int. 2012 Feb;81(4):363-9
(18) Effect of extracorporeal cytokine removal on vascular barrier function in a septic shock patient
S. David, K. Thamm, B. M. W. Schmidt, C. S. Falk and J. T. Kielstein
Journal of Intensive Care (2017) 5:12

Re-direction of cellular immune defense

(19) Hemoadsorption Reprograms Inflammation in Experimental Gram-Negative Septic Peritonitis: Insights from In Vivo and In Silico Studies.
Namas RA, Namas R, Lagoa C, Barclay D, Mi Q, Zamora R, Peng Z, Wen X, Fedorchak MV, Valenti IE, Federspiel WJ, Kellum JA, Vodovotz Y
Mol Med. 2012 Dec 20;18:1366-74
(20) Modulation of chemokine gradients by apheresis redirects leukocyte trafficking to different compartments during sepsis, studies in a rat model.
Peng ZY, Bishop JV, Wen XY, Elder MM, Zhou F, Chuasuwan A, Carter MJ, Devlin JE, Kaynar AM, Singbartl K, Pike F, Parker RS, Clermont G, Federspiel WJ, Kellum JA.
Crit Care. 2014 Jul 3;18(4):R141

Prevention or slowing down of excessive systemic inflammation

(21) Treatment of post-cardiopulmonary bypass SIRS by hemoadsorption: a case series
Trager K, Fritzler D, Fischer G, Schroder J, Skrabal C, Liebold A, Reinelt H
Int J Artif Organs 2016; 39(3): 141-146
(22) Systemic Inflammatory Response Syndrome in der Herzchirurgie: Neue Therapiemöglichkeiten durch den Einsatz eines Cytokin-Adsorbers während EKZ?
Born F, Pichlmaier M, Peterß S, Khaladj N, Hagl C
Kardiotechnik 2/2014

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