Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Fuzhou General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Model for end-stage liver disease （MELD score）
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
simple plasma exchange group
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.
Intervention: simple plasma exchange (Procedure)
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.
Intervention: conventional PDF treatment group (Procedure)
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.
Intervention: less plasma PDF treatment group (Procedure)
Outcomes
Primary Outcomes
Model for end-stage liver disease （MELD score）
Time Frame: 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 Outcomes
- cytokine(Month 3)
- the number of artificial liver treatment(Month3)
- sequential organ failure assessment score（SOFA score）(Month 3)
- survival rate(Month 3)
- blood platelet count(Month 3)
- the concentration of plasma ammonia(Month 3)
Investigators
Dongliang Li
professor
Fuzhou General Hospital