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NCT Number: NCT05030571

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location status: Recruiting

Location contact

Sasipha Tachaboon

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Pregnancy
  • Received steroid treatment
  • Expected dead within 24 hour
  • WBC < 500/mm3
  • Allergy to DPMAS
  • History of organ transplant
  • Terminal illness with do not resuscitation order

Treatment and study plan

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

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

Primary outcomes

  1. mHLA-DR expression

    Time frame: 7 days

    mHLA-DR expression

Secondary outcomes

  1. survival rate

    Time frame: 28 days

    survival rate

  2. Reduction of total bilirubin

    Time frame: 7 days

    Reduction of total bilirubin

  3. hepatic encephalopathy grading

    Time frame: 28 days

    hepatic encephalopathy grading

  4. subsequent bacterial infection

    Time frame: 28 days

    subsequent bacterial infection

  5. CD11b expression

    Time frame: 7 days

    CD11b expression

Study contacts

Contact information is provided by the study sponsor or research team.

Phatadon Sirivongrangson, MD

CONTACT

[email protected]

(+66)0852447788

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 1, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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