Hepatic FailureNCT03560414
The Plasma Diafiltration Therapy of Hepatic Failure
A study testing simple plasma exchange, conventional PDF treatment group and less plasma PDF treatment group in people with Hepatic Failure and Plasma Exchange, run by Fuzhou General Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatic Failure, Plasma Exchange
- What is being tested?
- simple plasma exchange, conventional PDF treatment group and less plasma PDF treatment group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jun 2018to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatic failure on Medium period
- Model for End-Stage Liver Disease (MELD) <30 and >20
- age > 18 years and <70years
- Written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure
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.
- Conditions
- Hepatic Failure, Plasma Exchange
- Being tested
- simple plasma exchange, conventional PDF treatment group, less plasma PDF treatment group
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simple plasma exchangeProcedure or surgery
simple plasma exchange treatment
conventional PDF treatment groupProcedure or surgery
conventional PDF treatment group
less plasma PDF treatment groupProcedure or surgery
less plasma Plasma diafiltration treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: less plasma PDF treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)。
Measured: month 3
Secondary outcomes (6)
cytokine
The concentration of cytokines（TNF-α、IL-６、IL-８、IL-10）will be tested
Measured: Month 3
blood platelet count
To observe the changes in platelet count before and after the treatment
Measured: Month 3
the number of artificial liver treatment
Count the number of artificial liver treatments during hospitalization
Measured: Month3
the concentration of plasma ammonia
To observe the changes of plasma ammonia before and after the treatment
Measured: Month 3
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）
Measured: Month 3
survival rate
To count the survival rate after the treatment
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startJun 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuzhou General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongliang Li, Fuzhou General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560414
- Sponsor's protocol ID
- 2017L09
- Status last verified
- Jun 2018
- First submitted
- 18 Feb 2018
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High - Flux Plasma Diafiltration Based on Plasma - Saved Mode in the Treatment of Patients With Hepatic Failure
- ClinicalTrials.gov ID
- NCT03560414
- Acronym / sponsor ID
- 2017L09
- Conditions
- Hepatic Failure, Plasma Exchange
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fuzhou General HospitalUniversity, hospital or other
- Study start
- Jun 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| simple plasma exchange group | Experimental | Procedure: simple plasma exchangeThe 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. |
| conventional PDF treatment group | Active comparator | Procedure: conventional PDF treatment groupThe 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. |
| less plasma PDF treatment group | Active comparator | Procedure: less plasma PDF treatment groupThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- hepatic failure on Medium period
- Model for End-Stage Liver Disease (MELD) <30 and >20
- age > 18 years and <70years
- Written informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simple plasma exchangesimple plasma exchange treatment | Procedure or surgery | simple plasma exchange group |
| conventional PDF treatment groupconventional PDF treatment group | Procedure or surgery | conventional PDF treatment group |
| less plasma PDF treatment groupless plasma Plasma diafiltration treatment | Procedure or surgery | less plasma PDF treatment group |
Primary outcome
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)。
6 secondary outcomes
cytokine
Time frame: Month 3
blood platelet count
Time frame: Month 3
the number of artificial liver treatment
Time frame: Month3
the concentration of plasma ammonia
Time frame: Month 3
sequential organ failure assessment score（SOFA score）
Time frame: Month 3
survival rate
Time frame: Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simple plasma exchange, conventional PDF treatment group and less plasma PDF treatment group in people with Hepatic Failure and Plasma Exchange, run by Fuzhou General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zhiyu zeng (008615880447131, 498289727@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model for end-stage liver disease （MELD score） (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.