NCT03560414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

February 18, 2018

Last Update Submit

June 6, 2018

Conditions

Hepatic FailurePlasma Exchange

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • cytokine

    Month 3

  • blood platelet count

    Month 3

  • the number of artificial liver treatment

    Month3

  • the concentration of plasma ammonia

    Month 3

  • sequential organ failure assessment score（SOFA score）

    Month 3

  • +1 more secondary outcomes

Study Arms (3)

simple plasma exchange group

EXPERIMENTAL

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.

Procedure: simple plasma exchange

conventional PDF treatment group

ACTIVE COMPARATOR

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.

Procedure: conventional PDF treatment group

less plasma PDF treatment group

ACTIVE COMPARATOR

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.

Procedure: less plasma PDF treatment group

Interventions

simple plasma exchangePROCEDURE

simple plasma exchange treatment

simple plasma exchange group
conventional PDF treatment groupPROCEDURE

conventional PDF treatment group

conventional PDF treatment group
less plasma PDF treatment groupPROCEDURE

less plasma Plasma diafiltration treatment

less plasma PDF treatment group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hepatic failure on Medium period
  • Model for End-Stage Liver Disease (MELD) \<30 and \>20
  • age \> 18 years and \<70years
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, 350025, China

Location

MeSH Terms

Conditions

Liver Failure

Condition Hierarchy (Ancestors)

Hepatic InsufficiencyLiver DiseasesDigestive System Diseases

Central Study Contacts

zhiyu zeng

CONTACT

008615880447131498289727@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

February 18, 2018

First Posted

June 18, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

June 18, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)