Hepatic Failure, Plasma Exchange
Conditions
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.
Interventions
PROCEDUREsimple plasma exchange
simple plasma exchange treatment
PROCEDUREconventional PDF treatment group
conventional PDF treatment group
PROCEDUREless plasma PDF treatment group
less plasma Plasma diafiltration treatment
Sponsors
Fuzhou General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Model for end-stage liver disease （MELD score） | month 3 | 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
| Measure | Time frame | Description |
|---|---|---|
| blood platelet count | Month 3 | To observe the changes in platelet count before and after the treatment |
| the number of artificial liver treatment | Month3 | Count the number of artificial liver treatments during hospitalization |
| cytokine | Month 3 | The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested |
| sequential organ failure assessment score（SOFA score） | Month 3 | 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 | Month 3 | To count the survival rate after the treatment |
| the concentration of plasma ammonia | Month 3 | To observe the changes of plasma ammonia before and after the treatment |
Countries
China
Contacts
Primary Contactzhiyu zeng
Outcome results
None listed