The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DPMAS, standard treatment.
- Who it may be relevant to
- Registry conditions: Acute-On-Chronic Liver Failure, Acute on Chronic Hepatic Failure. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Thailand
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device DPMAS
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) - Other standard treatment
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
Primary outcome measures
- mHLA-DR expression [Time frame: 7 days]
Secondary outcome measures (5)
- survival rate [Time frame: 28 days]
- Reduction of total bilirubin [Time frame: 7 days]
- hepatic encephalopathy grading [Time frame: 28 days]
- subsequent bacterial infection [Time frame: 28 days]
- CD11b expression [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Thailand · 1 center
- King Chulalongkorn Memorial Hospital — Bangkok
Identifiers
NCT: NCT05030571 · IRB.216/64