The Plasma Diafiltration Therapy of Hepatic Failure

NCT ID: NCT03560414

Last Updated: 2018-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Hepatic Failure Plasma Exchange

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

simple plasma exchange

Intervention Type PROCEDURE

simple plasma exchange treatment

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.

Group Type ACTIVE_COMPARATOR

conventional PDF treatment group

Intervention Type PROCEDURE

conventional 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.

Group Type ACTIVE_COMPARATOR

less plasma PDF treatment group

Intervention Type PROCEDURE

less plasma Plasma diafiltration treatment

Interventions

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simple plasma exchange

simple plasma exchange treatment

Intervention Type PROCEDURE

conventional PDF treatment group

conventional PDF treatment group

Intervention Type PROCEDURE

less plasma PDF treatment group

less plasma Plasma diafiltration treatment

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fuzhou General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongliang Li

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fuzhou General Hospital, Xiamen Univ

Fuzhou, Fujian, China

Site Status

Countries

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China

Central Contacts

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zhiyu zeng

Role: CONTACT

008615880447131

Other Identifiers

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2017L09

Identifier Type: -

Identifier Source: org_study_id

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