The Plasma Diafiltration Therapy of Hepatic Failure
- Conditions
- Hepatic FailurePlasma Exchange
- Interventions
- Procedure: conventional PDF treatment groupProcedure: simple plasma exchangeProcedure: less plasma PDF treatment group
- Registration Number
- NCT03560414
- Lead Sponsor
- Fuzhou General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- hepatic failure on Medium period
- Model for End-Stage Liver Disease (MELD) <30 and >20
- age > 18 years and <70years
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description conventional PDF treatment group conventional PDF treatment group 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. simple plasma exchange group simple plasma exchange 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. less plasma PDF treatment group less plasma PDF treatment group 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method cytokine Month 3 The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested
the number of artificial liver treatment Month3 Count the number of artificial liver treatments during hospitalization
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
blood platelet count Month 3 To observe the changes in platelet count before and after the treatment
the concentration of plasma ammonia Month 3 To observe the changes of plasma ammonia before and after the treatment
Trial Locations
- Locations (1)
Fuzhou General Hospital, Xiamen Univ
🇨🇳Fuzhou, Fujian, China