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CytoSorb® is CE-mark approved in the E.U. in the U.S., CytoSorb® and DrugSorb-ATR® are investigational devices not yet FDA authorized/approved/cleared.
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Liver

Supporting your patient’s liver

Hepatic dysfunction impairs essential liver functions, including detoxification, synthetic capacity, and metabolic regulation, and is associated with high mortality among intensive care unit patients. Extracorporeal liver support systems are intended to assist hepatic detoxification by facilitating the removal of hepatotoxic substances from the blood. CytoSorb® Therapy is approved, according to its intended use and applicable regulatory approvals, for the extracorporeal removal of bilirubin from blood.

Liver Support

One of the main challenges in Acute Liver Dysfunction (ALD) is auto-intoxication caused by substances normally metabolized or excreted by the liver, such as bilirubin, bile acids, ammonia, and others. Liver auto-intoxication and the systemic hyperinflammation that often accompanies ALD may contribute to progression toward Multi Organ Dysfunction Syndrome (MODS).

 

CytoSorb® Therapy is designed to support the reduction of bilirubin and inflammatory mediators as part of a multimodal approach to managing auto-intoxication and immune dysregulation.

Liver support by CytoSorb

CytoSorb is a technology proven to effectively, safely, and simultaneously reduce elevated levels of cytokines and bilirubin, thereby promoting hemodynamic stability and support of excretory liver function.

Hemoadsorption has a different mode of action than dialysis-based therapies have, effectively removing excessive levels of cytokines. Early attenuation of auto-intoxication (and hyperinflammation) can help as a bridging therapy towards liver recovery or transplantation.

 

  • Removal of:
    • Bilirubin
    • Cytokines
  • May support:
    • Liver function improvement
    • Clinical management
    • Hemodynamic stabilization

CytoSorb can be used as part of a multimodal approach to address various challenges associated with liver dysfunction

Acute Liver Failure Acute-on-Chronic Liver Failure Acute Liver Dysfunction

Manage liver dysfunction

Liver dysfunction can occur in various settings, such as acute-on-chronic liver failure, post-hepatectomy liver failure (PHLF), and acute liver failure.

 

CytoSorb removes bilirubin efficiently, and addresses systemic hyperinflammation via cytokine removal.

Building a bridge with CytoSorb

Reduction of systemic inflammation, together with support of excretory liver function, could help bridging patients toward liver stabilization, recovery, or transplantation as part of a multimodal treatment strategy.

CytoSorb Therapy may support the management of liver dysfunction:

Effective bilirubin removal
Support of hepatic excretory function
Attenuation of hyperinflammation

Acute Liver Failure & Secondary Liver Dysfunction

General Treatment Goals

CytoSorb Therapy is intended to reduce excessive levels of bilirubin and cytokines. Through these therapeutic measures, the liver tissue could be supported by lower accumulation of bilirubin molecules as well as dampened local and systemic inflammatory pathways.

  		•
    Patient Selection
    Timing
    Dosing

    Highly Recommended
    • Bilirubin >20 mg/dL or dynamic increase of > 50% / 24hrs.
    • Documented hyperinflammation incl vasoplegic shock
      CRRT requirement
    • Hepatic encephalopathy West Haven ≥ 3
    • Within 12-24 hrs. after onset organ failure
    • Exchange: Adsorber exchanges after 6 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, shock reversal, NE< 0.05 μg/kg/min

    Recommended
    • Bilirubin > 10 mg/dL and/or:
    • Documented hyperinflammation
    • CRRT requirement
    • Refractory pruritus (ALF)
    • Start within 24-36 hrs.
    • Exchange: Adsorber exchanges after 8 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, hemodynamic stabilization

    Highly Recommended

    • Bilirubin >20 mg/dL or dynamic increase of > 50% / 24hrs.
    • Documented hyperinflammation incl vasoplegic shock
      CRRT requirement
    • Hepatic encephalopathy West Haven ≥ 3
    • Within 12-24 hrs. after onset organ failure
    • Exchange: Adsorber exchanges after 6 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, shock reversal, NE< 0.05 μg/kg/min

    Recommended

    • Bilirubin > 10 mg/dL and/or:
    • Documented hyperinflammation
    • CRRT requirement
    • Refractory pruritus (ALF)
    • Start within 24-36 hrs.
    • Exchange: Adsorber exchanges after 8 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, hemodynamic stabilization

  • Therapy Goals

    • Supporting restoration of liver functions
    • Controlling systemic hyperinflammation
    • Bridging to transplantation

  • Principles

    • Start early enough to remove liver toxins and restore organ function
    • Control of hyperinflammation for hemodynamic stabilization

Acute on Chronic Liver Dysfunction (ACLF)

General Treatment Goals

CytoSorb Therapy is intended to reduce excessive levels of bilirubin and cytokines. Through these therapeutic measures, the liver tissue could be supported by lower accumulation of bilirubin molecules as well as dampened local and systemic inflammatory pathways.

  		•
    Patient Selection
    Timing
    Dosing

    Highly Recommended
    • ACLF I/II with
    • Bilirubin ≥ 12 mg/dl or dynamic increase of > 50% / 24hrs.
    • No respiratory organ failure
    • No uncontrolled infection
    • No active esophageal variceal bleeding
    • Within 12-24 hrs. after onset organ failure
    • Exchange: Adsorber exchanges after 6 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL,
      HE WH ≤ 2, shock reversal, NE< 0.05 μg/kg/min and/or ACLF 0 / LTx
    • Pruritus: 6-9 adsorbers within 3 consecutive days

    Recommended
    • ACLF I/II with
    • Bilirubin ≥ 12 mg/dl
    • Refractory pruritus (ACLF)
    • Start within 24-36 hrs.
    • Exchange: Adsorber exchanges after 8 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, hemodynamic stabilization and/or ACLF I / LTx

    Highly Recommended

    • ACLF I/II with
    • Bilirubin ≥ 12 mg/dl or dynamic increase of > 50% / 24hrs.
    • No respiratory organ failure
    • No uncontrolled infection
    • No active esophageal variceal bleeding
    • Within 12-24 hrs. after onset organ failure
    • Exchange: Adsorber exchanges after 6 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL,
      HE WH ≤ 2, shock reversal, NE< 0.05 μg/kg/min and/or ACLF 0 / LTx
    • Pruritus: 6-9 adsorbers within 3 consecutive days

    Recommended

    • ACLF I/II with
    • Bilirubin ≥ 12 mg/dl
    • Refractory pruritus (ACLF)
    • Start within 24-36 hrs.
    • Exchange: Adsorber exchanges after 8 hrs. if ongoing reduction is needed
    • Duration: Until bilirubin levels < 8 mg/dL, HE WH ≤ 2, hemodynamic stabilization and/or ACLF I / LTx

  • Therapy Goals

    • Supporting restoration of liver functions
    • Controlling systemic hyperinflammation
    • Bridging to transplantation
    • Attenuating pruritus

  • Principles

    • Start early enough to remove liver toxins and restore organ function
    • Control of hyperinflammation for hemodynamic stabilization
    • Reduce symptoms of refractory pruritus

Additional Information

Download file
Flowchart Recommended literature Evolution of evidence
  • Haselwanter et al., Sci Rep 2024; 14(1):11309
  • Turan et al., Biomedicines 2024; 12(1):67
  • Riva et al., J Art Orgs 2023; epub
  • Popescu et al., J Clin Med 2023; 12(6):2258
  • Greimel et al., Ann Intensive Care 2023; 13(1):110
  • Tomescu et al., Int J Artif Organs 2021; 4(8):560-564
  • Jansen et al., Crit Care 2023; 27(1):117
  • Riva et al., J Artif Organs 2024; 27(3):261-268
  • Forni et al., BMC Neph 2024; 25(1):247
  • Dhokia et al., JICS, 2019; Vol. 20(2):174-181
  • Frattari et al, Blood Purif 2019; 47(suppl 4):3-37
  • Scharf et al., Scientific Reports 2021; 11:10190
  • Graefe et al., Sci Rep 2024; 14(1):21762
  • Albrecht et al., Blood Purif 2024; 52(2):88-95
  • Chavez et al. Crit Care 2016; 20(1):135

CytoSorb 300 IFU 03/2023 – Indications:
CytoSorb is indicated for use in conditions where elevated levels of cytokines and/or bilirubin and/or myoglobin exist. CytoSorb is indicated for use intraoperatively during cardio-pulmonary bypass surgery for the removal of P2Y12-Inhibitor Ticagrelor and/or Factor Xa-Inhibitor Rivaroxaban. Results from current studies suggest that CytoSorb may be administered for up to 7 consecutive days. Maximum Treatment Time per Device: 24 Hour.

Access Healthcare Professionals Area

This area is for Health Care Professionals only and provides reports about clinical experiences gained during the use of CytoSorbents products. The information presented reflects the opinions and procedural techniques of individual physicians and is not intended as medical advice. Physician experience, risks, patient outcomes and results may vary. This content is intended for Health Care Professionals outside the United States and Canada as CytoSorb has not yet been approved or cleared in the United States or Canada for any indication, except under an Emergency Use Authorization (EUA) by the US FDA.