The Plasma Diafiltration Therapy of Hepatic Failure

Hepatic Failure Clinical Trial

Official title:

Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03560414
• Other study ID #: 2017L09
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2018
• Est. completion date: December 2020

Study information

• Verified date: June 2018
• Source: Fuzhou General Hospital
• Contact: zhiyu zeng
• Phone: 008615880447131
• Email: 498289727[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Failure
• Liver Failure
• Plasma Exchange

Intervention

Procedure:
• simple plasma exchange
simple plasma exchange treatment
• conventional PDF treatment group
conventional PDF treatment group
• less plasma PDF treatment group
less plasma Plasma diafiltration treatment

Locations

Country	Name	City	State
China	Fuzhou General Hospital, Xiamen Univ	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fuzhou General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)?	month 3
Secondary	cytokine	The concentration of cytokines(TNF-a?IL-6?IL-8?IL-10)will be tested	Month 3
Secondary	blood platelet count	To observe the changes in platelet count before and after the treatment	Month 3
Secondary	the number of artificial liver treatment	Count the number of artificial liver treatments during hospitalization	Month3
Secondary	the concentration of plasma ammonia	To observe the changes of plasma ammonia before and after the treatment	Month 3
Secondary	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)	Month 3
Secondary	survival rate	To count the survival rate after the treatment	Month 3