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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
simple plasma exchange treatment
conventional PDF treatment group
less plasma Plasma diafiltration treatment
Fuzhou General Hospital, Xiamen Univ
Fuzhou, Fujian, China
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)。
Time frame: month 3
cytokine
The concentration of cytokines(TNF-α、IL-6、IL-8、IL-10)will be tested
Time frame: Month 3
blood platelet count
To observe the changes in platelet count before and after the treatment
Time frame: Month 3
the number of artificial liver treatment
Count the number of artificial liver treatments during hospitalization
Time frame: Month3
the concentration of plasma ammonia
To observe the changes of plasma ammonia before and after the treatment
Time frame: 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)
Time frame: Month 3
survival rate
To count the survival rate after the treatment
Time frame: Month 3
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