Protocolised Management of Phosphate Replacement Trial

NCT ID: NCT07288944

Last Updated: 2025-12-17

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-12-31

Brief Summary

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The aim of this cluster, crossover, randomised controlled trial is to compare two standard arms of treatment for the replacement of phosphate in critically ill patients.

We hypothesise that protocolised restricted phosphate replacement, compared to protocolised liberal phosphate replacement, will result in reduced administration of phosphate with similar clinical outcomes.

All eligible Intensive Care Unit (ICU) patients will be included during their admission with the selected protocol for that period as per usual practice and treatment standards.

Detailed Description

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This study looks to compare liberal and restrictive phosphate replacement protocols (each arm is a current "standard of care" already used in practice) to investigate whether restrictive phosphate replacement in critically ill patients leads to reduced phosphate administration and/or equivalent patient outcomes.

Derangements of serum phosphate concentrations are common among ICU patients; high and low levels variably associated with worse outcomes. The PROMPT trial will compare two standard arms of treatment for the replacement of phosphate in critically ill patients. Phosphate is currently replaced routinely in ICU's however there is not a standardised evidence-based guideline to effectively guide phosphate administration for ICU patients

This is a cluster, crossover, electronic medical record integrated, randomised, controlled trial. Sites (not patients) will be randomised to wither the liberal or restrictive phosphate replacement protocol for a 6-month period, followed by a 1-month washout period, before switching to the next protocol for the preceding 6-month period. The allocated phosphate replacement protocol will be updated in the electronic medical record to be followed; this process is already part of normal clinical practice.

Conditions

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Phosphate Deficiency Hypophosphatemia Protocol Optimization Critical Care, Intensive Care

Keywords

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Phosphate Protocol Critical Care Intensive Care Hypophosphatemia Phosphate Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A cluster, crossover, electronic medical record (EMR)-integrated, randomised, controlled trial (RCT) that will compare liberal versus restrictive protocolised replacement of phosphate in critically ill patients admitted to intensive care units (ICU).
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Liberal Phosphate Replacement Protocol

The liberal group, a recommendation for phosphate replacement would be given if the serum phosphate concentration was 0.79 mmol/L, but not if 0.80 mmol/L.

Group Type ACTIVE_COMPARATOR

Liberal Phosphate Replacement Protocol

Intervention Type OTHER

The liberal group, a recommendation for phosphate replacement would be given if the serum phosphate concentration was 0.79 mmol/L, but not if 0.80 mmol/L.

Conservative Phosphate Replacement Protocol

The restrictive protocol will recommend phosphate replacement to commence at a threshold of 0.50 mmol/L, and the liberal protocol at 0.80 mmol/L.

Group Type ACTIVE_COMPARATOR

Restrictive Phosphate Replacement Protocol

Intervention Type OTHER

The restrictive protocol will recommend phosphate replacement to commence at a threshold of 0.50 mmol/L, and the liberal protocol at 0.80 mmol/L.

Interventions

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Liberal Phosphate Replacement Protocol

The liberal group, a recommendation for phosphate replacement would be given if the serum phosphate concentration was 0.79 mmol/L, but not if 0.80 mmol/L.

Intervention Type OTHER

Restrictive Phosphate Replacement Protocol

The restrictive protocol will recommend phosphate replacement to commence at a threshold of 0.50 mmol/L, and the liberal protocol at 0.80 mmol/L.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All adult patients admitted to participating intensive care units during the study period.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Queensland University of Technology

OTHER

Sponsor Role collaborator

Caboolture Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mahesh Ramanan

Role: PRINCIPAL_INVESTIGATOR

+61 7 5433 8888

Central Contacts

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Mahesh Ramanan

Role: CONTACT

Phone: +61 7 5433 8888

Email: [email protected]

Emma L Williams

Role: CONTACT

Phone: +61 488 474 254

Email: [email protected]

References

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Ramanan M, Tabah A, Affleck J, Edwards F, White KC, Attokaran A, Laupland K. Hypophosphataemia in Critical Illness: A Narrative Review. J Clin Med. 2024 Nov 26;13(23):7165. doi: 10.3390/jcm13237165.

Reference Type BACKGROUND
PMID: 39685625 (View on PubMed)

Sin JCK, Laupland KB, Ramanan M, Tabah A. Phosphate abnormalities and outcomes among admissions to the intensive care unit: A retrospective multicentre cohort study. J Crit Care. 2021 Aug;64:154-159. doi: 10.1016/j.jcrc.2021.03.012. Epub 2021 Apr 18.

Reference Type BACKGROUND
PMID: 33906104 (View on PubMed)

Other Identifiers

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HREC/2025/MNH/121108

Identifier Type: -

Identifier Source: org_study_id