The Plasma Diafiltration Therapy of Hepatic Failure

Study Overview
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Brief Summary
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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.

Official Title
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Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure

Conditions
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Hepatic Failure, Plasma Exchange

Intervention / Treatment
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* Procedure: simple plasma exchange
* Procedure: conventional PDF treatment group
* Procedure: less plasma PDF treatment group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simple plasma exchange group<br>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. | Procedure: simple plasma exchange<br>* simple plasma exchange treatment<br>|
| Active Comparator: conventional PDF treatment group<br>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. | Procedure: conventional PDF treatment group<br>* conventional PDF treatment group<br>|
| Active Comparator: less plasma PDF treatment group<br>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. | Procedure: less plasma PDF treatment group<br>* less plasma Plasma diafiltration treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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)。 | month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cytokine | The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested | Month 3 | 
| blood platelet count | To observe the changes in platelet count before and after the treatment | Month 3 | 
| the number of artificial liver treatment | Count the number of artificial liver treatments during hospitalization | Month3 | 
| the concentration of plasma ammonia | To observe the changes of plasma ammonia before and after the treatment | Month 3 | 
| 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） | Month 3 | 
| survival rate | To count the survival rate after the treatment | Month 3 |