Clinical trial NCT05030571: The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
Official title: The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Acute on Chronic Hepatic Failure
Keywords: Hemoperfusion
Acute-On-Chronic Liver Failure
Cytokine adsorbant therapy
HA-330
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: mHLA-DR expression
timeFrame: 7 days
Secondary outcomes:
measure: survival rate
timeFrame: 28 days
measure: Reduction of total bilirubin
timeFrame: 7 days
measure: hepatic encephalopathy grading
timeFrame: 28 days
measure: subsequent bacterial infection
timeFrame: 28 days
measure: CD11b expression
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
Study officials:
References: