The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChulalongkorn University

About this trial

Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections.

Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored.

Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients.

Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 or more

Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria

Admitted to intensive care unit

Disqualifiers

Pregnancy

Received steroid treatment

Expected dead within 24 hour

WBC < 500/mm3

Trial design

Design model

Parallel

Treatments tested in this trial

  • DPMAS

    Device

    DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China)

  • standard treatment

    Other intervention

    standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

mHLA-DR expression

mHLA-DR expression

Time frame
7 days

Secondary outcomes

1

survival rate

survival rate

Time frame
28 days
2

Reduction of total bilirubin

Reduction of total bilirubin

Time frame
7 days
3

hepatic encephalopathy grading

hepatic encephalopathy grading

Time frame
28 days
4

subsequent bacterial infection

subsequent bacterial infection

Time frame
28 days

Other outcomes

Sponsors and contacts

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