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

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05030571
• Other study ID #: IRB.216/64
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: Phatadon Sirivongrangson, MD
• Phone: (+66)0852447788
• Email: phatadon[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Hepatic Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Liver Failure

Intervention

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.

Locations

Country	Name	City	State
Thailand	King Chulalongkorn Memorial Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mHLA-DR expression	mHLA-DR expression	7 days
Secondary	survival rate	survival rate	28 days
Secondary	Reduction of total bilirubin	Reduction of total bilirubin	7 days
Secondary	hepatic encephalopathy grading	hepatic encephalopathy grading	28 days
Secondary	subsequent bacterial infection	subsequent bacterial infection	28 days
Secondary	CD11b expression	CD11b expression	7 days