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

Primary Purpose

Acute-On-Chronic Liver Failure, Acute on Chronic Hepatic Failure

Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
DPMAS
standard treatment
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring Hemoperfusion, Acute-On-Chronic Liver Failure, Cytokine adsorbant therapy, HA-330

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • King Chulalongkorn Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Standard care

Arm Description

Intervention group will receive DPMAS extracorporeal treatment one session per day for 3 consecutive days plus standard therapy. We plan to use blood flow rate of 100-120 ml/hour with filtration fraction for plasma separation of 25-30%. 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) We do not use any anticoagulant.

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

Outcomes

Primary Outcome Measures

mHLA-DR expression
mHLA-DR expression

Secondary Outcome Measures

survival rate
survival rate
Reduction of total bilirubin
Reduction of total bilirubin
hepatic encephalopathy grading
hepatic encephalopathy grading
subsequent bacterial infection
subsequent bacterial infection
CD11b expression
CD11b expression

Full Information

First Posted
August 26, 2021
Last Updated
July 19, 2023
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT05030571
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-On-Chronic Liver Failure, Acute on Chronic Hepatic Failure
Keywords
Hemoperfusion, Acute-On-Chronic Liver Failure, Cytokine adsorbant therapy, HA-330

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention group will receive DPMAS extracorporeal treatment one session per day for 3 consecutive days plus standard therapy. We plan to use blood flow rate of 100-120 ml/hour with filtration fraction for plasma separation of 25-30%. 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) We do not use any anticoagulant.
Arm Title
Standard care
Arm Type
Active Comparator
Arm Description
Standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017
Intervention Type
Device
Intervention Name(s)
DPMAS
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
Primary Outcome Measure Information:
Title
mHLA-DR expression
Description
mHLA-DR expression
Time Frame
7 days
Secondary Outcome Measure Information:
Title
survival rate
Description
survival rate
Time Frame
28 days
Title
Reduction of total bilirubin
Description
Reduction of total bilirubin
Time Frame
7 days
Title
hepatic encephalopathy grading
Description
hepatic encephalopathy grading
Time Frame
28 days
Title
subsequent bacterial infection
Description
subsequent bacterial infection
Time Frame
28 days
Title
CD11b expression
Description
CD11b expression
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Phatadon Sirivongrangson, MD
Phone
(+66)0852447788
Email
phatadon@hotmail.com
Facility Information:
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasipha Tachaboon

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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