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Trial registered on ANZCTR


Registration number
ACTRN12623001152617
Ethics application status
Approved
Date submitted
3/10/2023
Date registered
8/11/2023
Date last updated
15/05/2024
Date data sharing statement initially provided
8/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-centre feasibility study to evaluate the ability of Phoxilium to prevent hypophoshatemia compared to Hemosol B0 or Prismocol B22 during continuous renal replacement therapy in the intensive care unit
Scientific title
Evaluation of Phoxilium® to Prevent HypoPHOSPHATEmia compared to Hemosol B0® or Prismocol B22 during Citrate-based Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)
Secondary ID [1] 310273 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury 330967 0
Condition category
Condition code
Renal and Urogenital 327767 327767 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phoxilum® (Baxter Healthcare Ltd., Norfolk, UK) is a commercially available phosphate-containing replacement fluid. Use of Phoxilum® during continuous renal replacement therapy will be in accordance with the Austin Health intensive care unit guidelines titled 'Continuous renal replacement therapy in the intensive care unit'. During therapy the patient's treating Intensive Care Consultant will prescribe or review the mode and duration of continuous renal replacement therapy on a daily basis. Adherence to continuous renal replacement therapy will be monitored by medical record review.

As this is a cross-over trial, if a patient is is first allocated to continuous renal replacement therapy with Phoxilum®, then their first circuit will use Phoxilum® as the replacement fluid. When the first circuit is discontinued, the comparator replacement fluid, this being Hemosol B0®, will be used for the second circuit. The washout period is the duration of time taken to set-up and commence continuous renal replacement therapy using the second circuit.
Intervention code [1] 326652 0
Prevention
Comparator / control treatment
Hemosol B0® and Prismocol B22® are a commercially available non-phosphate-containing replacement fluid. Use of Hemosol B0® and Prismocol B22® during continuous renal replacement therapy will be in accordance with the Austin Health intensive care unit guidelines titled 'Continuous renal replacement therapy in the intensive care unit'. During therapy the patient's treating Intensive Care Consultant will prescribe or review the mode and duration of continuous renal replacement therapy on a daily basis. Adherence to continuous renal replacement therapy will be monitored by medical record review.

As this is a cross-over trial, if a patient is is first allocated to continuous renal replacement therapy with Hemosol B0® or Prismocol B22®, then their first circuit will use Hemosol B0® or Prismocol B22® as the replacement fluid. When the first circuit is discontinued, the comparator replacement fluid, this being Phoxilum®, will be used for the second circuit. The washout period is the duration of time taken to set-up and commence continuous renal replacement therapy using the second circuit.
Control group
Active

Outcomes
Primary outcome [1] 335566 0
To describe the difference in daily blood phosphate levels in patients receiving a replacement fluid called Phoxilium compared to a replacement fluid called Hemosol B0 during citrate-based continuous renal replacement therapy (CRRT) in the intensive care unit (ICU).
Timepoint [1] 335566 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [1] 424969 0
Continuous renal replacement therapy circuit life-span
Timepoint [1] 424969 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [2] 424970 0
Changes in daily serum urea levels
Timepoint [2] 424970 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [3] 424971 0
Changes in daily serum creatinine levels
Timepoint [3] 424971 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [4] 424972 0
Changes in daily serum ionized calcium levels
Timepoint [4] 424972 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [5] 424973 0
Changes in acid-base state
Timepoint [5] 424973 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.
Secondary outcome [6] 424974 0
Volume of phosphate supplementation given during continuous renal replacement therapy
Timepoint [6] 424974 0
From the start of continuous renal replacement therapy to the end of renal replacement therapy during admission to the intensive care unit as recorded in the electronic medical record.

Eligibility
Key inclusion criteria
Patients will be included from the study if ALL the following criteria are present:
Have severe acute kidney injury.
Continuous renal replacement therapy is to commence.
Will receive regional citrate anticoagulation as a component of CRRT.
Expected to receive CRRT for equal to or greater than 48 hours.
The treating clinician believe that using Phoxilium® or Hemosol B0 are equally indicated and appropriate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be EXCLUDED from the study if ONE of the following criteria presents:
Age is less than 18 years of age.
Pregnancy
Not For Resuscitation (NFR) order in place during the index intensive care unit admission
Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment.
Patients with known HIV infection
Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with subject’s participation in this study.
Patient needs to receive systemic anticoagulation for other indications.

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 will be used to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
A study of 28 patients, will have an 80% power to identify a difference in phosphate levels from 0.7 mmol/L (standard deviation of 0.28) in the HemosolB0 group to 1.0 mmol/L with Phoxilium at an alpha of 0.05. We will randomize 30 patients to adjust for early circuit loss due to recovery or mortality.

Statistical analysis will be performed using computerised software (Stata MP/16.0, StataCorp, College Station, Texas, USA). Baseline characteristics will be reported as frequencies and percentages, means with plus or minus standard deviation, or medians and interquartile ranges. Summary statistics to compare baseline characteristics will include t-test, chi squared test, and Wilcoxon rank sum test, as dictated by data type. The primary outcome will be reported using multivariable mixed effects linear regression models. Secondary outcomes will be explored using multivariable linear regression models for continuous outcomes and logistic regression models for binary outcomes. No imputation will be performed for missing data. A two-sided p-value <0.05 will be considered significant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/11/2023
Actual
5/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25306 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 40982 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 314479 0
Hospital
Name [1] 314479 0
Austin Health
Country [1] 314479 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 316434 0
Individual
Name [1] 316434 0
Dr Heidi Gaulke
Address [1] 316434 0
Office for Research Austin Health 145 Studley Road Heidelberg VIC 3084
Country [1] 316434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313530 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313530 0
145 Studley Road Heidelberg VIC 3084
Ethics committee country [1] 313530 0
Australia
Date submitted for ethics approval [1] 313530 0
03/08/2023
Approval date [1] 313530 0
02/10/2023
Ethics approval number [1] 313530 0
HREC/101132/Austin-2023

Summary
Brief summary
During continuous renal replacement therapy in critically ill patients with acute kidney injury, electrolyte imbalances, including phosphate imbalances, may occur. Hemosol B0® and Phoxilium® are two routinely used replacement fluids during continuous renal replacement therapy for critically ill patients admitted to the Austin Hospital's Intensive Care Unit.
In our 30-patient, single-centre, open-label, prospective, randomised cross-over, feasibility study, we will investigate whether, compared with Hemosol B0, Phoxilium® replacement fluid achieves higher phosphate levels during continuous renal replacement therapy in critically ill patients with acute kidney injury.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128466 0
Prof Rinaldo Bellomo
Address 128466 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 128466 0
Australia
Phone 128466 0
+61 394965992
Fax 128466 0
+61394963932
Email 128466 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 128467 0
Prof Rinaldo Bellomo
Address 128467 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 128467 0
Australia
Phone 128467 0
+61 394965992
Fax 128467 0
+61394963932
Email 128467 0
rinaldo.bellomo@austin.org.au
Contact person for scientific queries
Name 128468 0
Prof Rinaldo Bellomo
Address 128468 0
Department of Intensive Care, Austin Hospital, 145 Studley Road, Heidelberg, Victoria, Australia 3084
Country 128468 0
Australia
Phone 128468 0
+61 394965992
Fax 128468 0
+61394963932
Email 128468 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a single-centre, pilot safety, feasibility trial of which the results will be considered hypothesis-generating.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20570Ethical approval    386352-(Uploaded-03-10-2023-10-50-27)-Study-related document.pdf



Results publications and other study-related documents

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