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Trial registered on ANZCTR

Registration number

ACTRN12622001040752p

Ethics application status

Not yet submitted

Date submitted

21/07/2022

Date registered

26/07/2022

Date last updated

26/07/2022

Date data sharing statement initially provided

26/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

A Pilot, Safety, Feasibility and Efficacy Trial of Hemoperfusion during Continuous Renal Replacement Therapy in Critically Ill Patients with Combined Liver and Kidney Failure

Scientific title

A Pilot, Safety, Feasibility and Efficacy Trial of Hemoperfusion during Continuous Renal Replacement Therapy in Critically Ill Patients with Combined Liver and Kidney Failure

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Liver failure

Kidney failure

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Following confirmation of eligibility and randomisation, a member of the investigating team will either add a hemoperfusion cartridge (HA330-II Jafron, Guangdong, China) for 12 hours and then changed to a new cartridge for a total of 2 cartridges over 24 hours of treatment for enrolled participants who receive standard continuous renal replacement therapy therapy in the intensive care unit, followed or preceded (by random allocation) the use of the standard care hemofiltration cartridge without a washout period during continuous renal replacement therapy.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Standard therapy for continuous renal replacement therapy during admission to the intensive care unit.

Control group

Active

Outcomes

Primary outcome [1]

Ammonia clearance by the extracorporeal circuit during the 24 hours after commencement of hemoperfusion cartridge therapy during continuous renal replacement therapy.

Timepoint [1]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [1]

Change in serum bilirubin levels over the 24 hour treatment period from the commencement of continuous renal replacement therapy with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [1]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [2]

Change in serum bile acid levels over the 24 hour treatment period from the commencement of continuous renal replacement therapy with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [2]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [3]

Change in ammonia levels over the 24 hour treatment period from the commencement of continuous renal replacement therapy with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [3]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [4]

Change in bile acids levels over the 24 hour treatment period from the commencement of continuous renal replacement therapy with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [4]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [5]

Change in serum bilirubin levels over the 24 hour treatment period from the commencement of continuous renal replacement therapy with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [5]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [6]

Trans-cartridge extraction ratio for serum ammonia between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [6]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [7]

Trans-cartridge extraction ratio for serum bilirubin between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [7]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [8]

Trans-cartridge extraction ratio for serum bile acids between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment

Timepoint [8]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [9]

Trans-filter extraction ratio for serum ammonia between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [9]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [10]

Trans-filter extraction ratio for serum bilirubin between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [10]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Secondary outcome [11]

Trans-filter extraction ratio for serum bile acids between treatment with the hemoperfusion cartridge and during standard continuous renal replacement therapy treatment.

Timepoint [11]

As determined by blood sample analysis of the extracorporeal circuit at time zero (pre-intervention) and at the the end of the 24 hour treatment period of both intervention and standard care treatment periods continuous renal replacement therapy as recorded in the participant's medical record.

Eligibility

Key inclusion criteria

Liver failure and severe acute kidney injury requiring continuous renal replacement therapy
Expected to continue to receive continuous renal replacement therapy for equal to or greater than 48 hours from the time of enrolment

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Suspected or confirmed pregnancy
Do not resuscitate (DNR) order in place
Do not intubate (DNI) order in place
Death is deemed inevitable or imminent during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
Known human immunodeficiency virus (HIV) infection
Another illness is present that in the investigator’s judgement, will substantially increase the risk associated with the participants participant in the study

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Sealed opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Eligible patients will be randomisation via a sealed opaque envelope using block randomisation method stratified by site with variable block sizes will be performed.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Summary statistics will be used to describe the clinical data and presented as median with interquartile range (IQR) or percentages as appropriate. Fisher’s exact test will be used for the comparison of categorical data and the paired Wilcoxon test will be used to compare data between the active treatment group and the control group with statistical significance set a value of <0.05.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

3/10/2022

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

20

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3084 - Banyule

Recruitment outside Australia

Country [1]

France

State/province [1]

Bordeaux

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Jafron Biomedical Co, Guangdong, China

Address [1]

No 98 Technology Sixth
Road High-Tech Zone
Zhuhai
Guangdong, 5
19085
China

Country [1]

China

Primary sponsor type

Hospital

Name

Austin Health

Address

Austin Health
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Dr Heidi Gaulke

Address [1]

Manager, Office for Research
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country [1]

Australia

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Road
Heidelberg VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

29/07/2022

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

We are conducting a pilot, safety, feasibility, efficacy, crossover, open-label randomised controlled trial, of 20 adult critically ill patients, in the Departments of Intensive Care at the Austin Hospital and Bordeaux University Hospital.

Continuous renal replacement therapy (CRRT), an artificial means of providing kidney function support, is often required in acutely ill patients who are admitted to the intensive care unit (ICU). 

The aim of CRRT is to achieve adequate blood purification from kidney failure associated toxins (typically non-protein bound small solutes). However, there are additional toxins that are related to liver failure, which should be a target for effective removal but cannot be effectively removed by (e.g. ammonia and/or bilirubin) during the current approach to CRRT. In patients experiencing liver failure that is also complicated by kidney failure, an additional form of blood purification that can be easily added to the CRRT circuit would be desirable.
Such blood purification is now available in the form of hemoperfusion (HP). It consists of a biocompatible coated resin inside a cartridge, which can adsorb large amounts of multiple toxins even when they are protein bound. This new technology has now been used to treat patients with septic shock, COVID-19-related acute respiratory distress syndrome (ARDS) and hyperinflammation as well as the itch associated with end stage kidney disease and advance liver disease. The added form of hemoperfusion offers much promise as a way of detoxifying plasma in acutely ill liver patients admitted to ICU with kidney failure.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ian Baldwin

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61394964835

Fax

+61394963932

Email

[email protected]

Contact person for public queries

Name

Ian Baldwin

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61394964835

Fax

+61394963932

Email

[email protected]

Contact person for scientific queries

Name

Ian Baldwin

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084

Country

Australia

Phone

+61394964835

Fax

+61394963932

Email

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16702	Study protocol			[email protected]	Version 1, dated 25th May 2022; please use the abo... [More Details]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.