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A single-centre feasibility study to evaluate the ability of Phoxilium to prevent hypophoshatemia compared to Prismocol B22 during continuous renal replacement therapy in the intensive care unit

Evaluation of Phoxilium® to Prevent HypoPHOSPHATEmia compared to Prismocol B22 during Citrate-based Continuous Renal Replacement Therapy (CRRT) in the Intensive Care Unit (ICU)

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12623001152617
Enrollment
12
Registered
2023-11-08
Start date
2023-12-05
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

During continuous renal replacement therapy in critically ill patients with acute kidney injury, electrolyte imbalances, including phosphate imbalances, may occur. Prismocal B22 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, sbefore-and-after study study, we will investigate whether, compared with Prismocal B22, Phoxilium® replacement fluid achieves higher phosphate levels during continuous renal replacement therapy in critically ill patients with acute kidney injury.

Interventions

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. Adhe

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. This is a single-centre before-and-after study. In the before period of study, between 1st December 2023 until 30th June 2024, we will include patients who received CRRT with Prismocal B22 as dialysate fluid and post-dilutional fluid for their first filter. These patients will serve as controls. In the after period, when Phoxilium has now become the default fluid, from 1st July 2024 until 31st December 2024, we will include patients who receive CRRT with Phoxilium as dialysate fluid and post-dilutional fluid for their first filter. We will compare data from the first filter and patients treated with Prismocal B22 before the introduction of Phoxilium to data from filters and patients treated with Phoxilium after its introduction as the default as dialysate fluid and post-dilutional fluid. This change was made after the enrolment of 5 participants.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients will be included from the study if ALL the following criteria are present: Have severe acute kidney injury or patients that have established end-stage kidney disease 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® are equally indicated and appropriate.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026