The Plasma Diafiltration Therapy of Hepatic Failure

900 Hospital of the People's Liberation Army Joint Logistic Support Force

Status: Unknown

Conditions: Plasma Exchange; Hepatic Failure

Treatments: Procedure: less plasma PDF treatment group; Procedure: simple plasma exchange; Procedure: conventional PDF treatment group

Study type: Interventional

Funder types: Other

Identifiers

NCT03560414

2017L09

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

simple plasma exchange group

Experimental group

Description:

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.

Treatment:

Procedure: simple plasma exchange

conventional PDF treatment group

Active Comparator group

Description:

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.

Treatment:

Procedure: conventional PDF treatment group

less plasma PDF treatment group

Active Comparator group

Description:

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.

Treatment:

Procedure: less plasma PDF treatment group