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The Plasma Diafiltration Therapy of Hepatic Failure

Primary Purpose

Hepatic Failure, Plasma Exchange

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
simple plasma exchange
conventional PDF treatment group
less plasma PDF treatment group
Sponsored by
Fuzhou General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hepatic failure on Medium period
  • Model for End-Stage Liver Disease (MELD) <30 and >20
  • age > 18 years and <70years
  • Written informed consent

Exclusion Criteria:

  • Active bleeding or disseminated intravascular coagulation
  • allergic to blood products or drugs such as plasma, heparin and protamine
  • hemodynamic instability
  • cardiovascular and cerebrovascular accidental infarction instability Period
  • extravascular hemolysis
  • severe sepsis
  • Tumor on ultrasonography, CT or MRI examination
  • Pregnant or lactating women

Sites / Locations

  • Fuzhou General Hospital, Xiamen Univ

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

simple plasma exchange group

conventional PDF treatment group

less plasma PDF treatment group

Arm Description

The mode is CVVH in CRRT machine, the treatment duration is 2h-3h, the application plasma volume is 40ml/Kg, the replacement fluid flow rate is 1000ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0ml/h.

The mode of conventional PDF treatment group is CVVHDF in CRRT machine, and the duration of treatment is 3 hours. the application plasma volume 1500 ml . The replacement fluid flow rate is 500 ml/h, the dialysate flow rate is 3000 ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0 ml/h.

The mode of conventional PDF treatment group is also CVVHDF in CRRT machine, and the duration of treatment is 3h. All patients are required to apply plasma 1000ml. Use plasma substitutes: 300ml NS+200ml 5% albumin. The replacement fluid flow rate is 500 ml/h, the dialysate flow rate is 3000 ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0 ml/h.

Outcomes

Primary Outcome Measures

Model for end-stage liver disease （MELD score）
MRLD=R=3.8ln[TBIL(mg/dl)]+11.2ln(INR)+9.6ln [Cr(mg/dl)]+6.4(etiology：Bile or alcoholic 0，others 1)。

Secondary Outcome Measures

cytokine
The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested
blood platelet count
To observe the changes in platelet count before and after the treatment
the number of artificial liver treatment
Count the number of artificial liver treatments during hospitalization
the concentration of plasma ammonia
To observe the changes of plasma ammonia before and after the treatment
sequential organ failure assessment score（SOFA score）
PaO₂（0：>53.33，1：39-53.33，2：26.66-40，3：13.33-26.67，4：≤13.33）；Platelet count（10/L）（0：>150，1：101-150，2：51-100，3：21-50，4：<21）；Respiratory support（3：NO，4：yes）；TBIL（0：<20，1：20-32，2：33-101，3：102-204，4：>204）；Glasgow Coma Scale（0：15，1：13～14，2：10～12，3：6～9，4：<6）；Cr(umol/L)（0：<110，1：110-170，2：171-299，3：300-440，4：>440）；Level of hypotension (vasopressor status for ≥1 hr)（0：No hypotension；1：MAP <70，2：On vasopressors, dopamine <5 µg/kg/min OR dobutamine (any dose)，3：Dopamine >5 µg/kg/min OR Epi/Norepi <0.1µg/kg/min；4：Dopamine >15 µg/kg/min OR Epi/Norepi >0.1 µg/kg/min）
survival rate
To count the survival rate after the treatment

Full Information

First Posted
February 18, 2018
Last Updated
June 6, 2018
Sponsor
Fuzhou General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03560414
Brief Title
The Plasma Diafiltration Therapy of Hepatic Failure
Official Title
Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2018 (Anticipated)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fuzhou General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
At present, there is no comparative study between the simple plasma exchange and plasma diafiltration (PDF), and no further exploration of optimal plasma dose in PDF treatment. Therefore, this prospective randomized cohort study aims to compare the safety and effectiveness of the tree groups（simple plasma exchange group, conventional PDF treatment group, less plasma PDF treatment group）by collecting SOFA score, 3-month survival rate, MELD score, and the times of artificial liver treatment , blood cell variables, cytokines(e.g. TNFα ), pre- and post-treatment plasma ammonia levels. Thus, it is to provide a safer and more effective artificial liver treatment with less plasma dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Failure, Plasma Exchange

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
simple plasma exchange group
Arm Type
Experimental
Arm Description
The mode is CVVH in CRRT machine, the treatment duration is 2h-3h, the application plasma volume is 40ml/Kg, the replacement fluid flow rate is 1000ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0ml/h.
Arm Title
conventional PDF treatment group
Arm Type
Active Comparator
Arm Description
The mode of conventional PDF treatment group is CVVHDF in CRRT machine, and the duration of treatment is 3 hours. the application plasma volume 1500 ml . The replacement fluid flow rate is 500 ml/h, the dialysate flow rate is 3000 ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0 ml/h.
Arm Title
less plasma PDF treatment group
Arm Type
Active Comparator
Arm Description
The mode of conventional PDF treatment group is also CVVHDF in CRRT machine, and the duration of treatment is 3h. All patients are required to apply plasma 1000ml. Use plasma substitutes: 300ml NS+200ml 5% albumin. The replacement fluid flow rate is 500 ml/h, the dialysate flow rate is 3000 ml/h, the blood flow rate is 100-140 ml/min, and the ultrafiltration volume is 0 ml/h.
Intervention Type
Procedure
Intervention Name(s)
simple plasma exchange
Intervention Description
simple plasma exchange treatment
Intervention Type
Procedure
Intervention Name(s)
conventional PDF treatment group
Intervention Description
conventional PDF treatment group
Intervention Type
Procedure
Intervention Name(s)
less plasma PDF treatment group
Intervention Description
less plasma Plasma diafiltration treatment
Primary Outcome Measure Information:
Title
Model for end-stage liver disease （MELD score）
Description
MRLD=R=3.8ln[TBIL(mg/dl)]+11.2ln(INR)+9.6ln [Cr(mg/dl)]+6.4(etiology：Bile or alcoholic 0，others 1)。
Time Frame
month 3
Secondary Outcome Measure Information:
Title
cytokine
Description
The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested
Time Frame
Month 3
Title
blood platelet count
Description
To observe the changes in platelet count before and after the treatment
Time Frame
Month 3
Title
the number of artificial liver treatment
Description
Count the number of artificial liver treatments during hospitalization
Time Frame
Month3
Title
the concentration of plasma ammonia
Description
To observe the changes of plasma ammonia before and after the treatment
Time Frame
Month 3
Title
sequential organ failure assessment score（SOFA score）
Description
PaO₂（0：>53.33，1：39-53.33，2：26.66-40，3：13.33-26.67，4：≤13.33）；Platelet count（10/L）（0：>150，1：101-150，2：51-100，3：21-50，4：<21）；Respiratory support（3：NO，4：yes）；TBIL（0：<20，1：20-32，2：33-101，3：102-204，4：>204）；Glasgow Coma Scale（0：15，1：13～14，2：10～12，3：6～9，4：<6）；Cr(umol/L)（0：<110，1：110-170，2：171-299，3：300-440，4：>440）；Level of hypotension (vasopressor status for ≥1 hr)（0：No hypotension；1：MAP <70，2：On vasopressors, dopamine <5 µg/kg/min OR dobutamine (any dose)，3：Dopamine >5 µg/kg/min OR Epi/Norepi <0.1µg/kg/min；4：Dopamine >15 µg/kg/min OR Epi/Norepi >0.1 µg/kg/min）
Time Frame
Month 3
Title
survival rate
Description
To count the survival rate after the treatment
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hepatic failure on Medium period Model for End-Stage Liver Disease (MELD) <30 and >20 age > 18 years and <70years Written informed consent Exclusion Criteria: Active bleeding or disseminated intravascular coagulation allergic to blood products or drugs such as plasma, heparin and protamine hemodynamic instability cardiovascular and cerebrovascular accidental infarction instability Period extravascular hemolysis severe sepsis Tumor on ultrasonography, CT or MRI examination Pregnant or lactating women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhiyu zeng
Phone
008615880447131
Email
498289727@qq.com
Facility Information:
Facility Name
Fuzhou General Hospital, Xiamen Univ
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350025
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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The Plasma Diafiltration Therapy of Hepatic Failure

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