Acute on Chronic Hepatic Failure, Acute-On-Chronic Liver Failure
Conditions
Keywords
Hemoperfusion, Acute-On-Chronic Liver Failure, Cytokine adsorbant therapy, HA-330
Brief summary
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
DEVICEDPMAS
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)
OTHERstandard treatment
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
Sponsors
Chulalongkorn University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or more 2. Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria 3. Admitted to intensive care unit
Exclusion criteria
1. Pregnancy 2. Received steroid treatment 3. Expected dead within 24 hour 4. WBC \< 500/mm3 5. Allergy to DPMAS 6. History of organ transplant 7. Terminal illness with do not resuscitation order
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mHLA-DR expression | 7 days | mHLA-DR expression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| survival rate | 28 days | survival rate |
| Reduction of total bilirubin | 7 days | Reduction of total bilirubin |
| hepatic encephalopathy grading | 28 days | hepatic encephalopathy grading |
| subsequent bacterial infection | 28 days | subsequent bacterial infection |
| CD11b expression | 7 days | CD11b expression |
Countries
Thailand
Contacts
CONTACTPhatadon Sirivongrangson, MD
Outcome results
None listed