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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simple plasma exchange group | Experimental | 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. |
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| conventional PDF treatment group | Active Comparator | 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. |
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| less plasma PDF treatment group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simple plasma exchange | Procedure | simple plasma exchange treatment |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhiyu zeng | Contact | 008615880447131 | 498289727@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuzhou General Hospital, Xiamen Univ | Fuzhou | Fujian | 350025 | China |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| conventional PDF treatment group |
| Procedure |
conventional PDF treatment group |
|
| less plasma PDF treatment group | Procedure | less plasma Plasma diafiltration 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 |