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NCT Number: NCT07288944

Protocolised Management of Phosphate Replacement Trial

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.

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Key information

Conditions

Phosphate Deficiency Critical Care, Intensive Care Hypophosphatemia Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders Protocol Optimization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All adult patients admitted to participating intensive care units during the study period.

Exclusion criteria

  • There will be no specific exclusion criteria

Treatment and study plan

Liberal Phosphate Replacement Protocol

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.

Restrictive Phosphate Replacement Protocol

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.

Primary outcomes

  1. non-inferiority for days alive and free of the intensive care unit (ICU) up to 30 days (DAF-ICU-30)

    Time frame: 30 Days post study enrolment

    The primary outcome will be assessed as non-inferiority in the number of days alive and free of ICU within 30 days from study enrolment. ICU length of stay will be used to calculate. This measure is reported on a continuous scale ranging from 0 (worst outcome: death or full ICU stay) to 30 (best outcome: alive and ICU-free for all 30 days), where higher scores indicate a better outcome. The difference between groups will be expressed as a mean difference with 95% confidence intervals.

Secondary outcomes

  1. Phosphate usage

    Time frame: individual arm and total quantities used over 12-month study period

    Quantities of intravenous and oral phosphate replaced (total and individually)

  2. Patients receiving phosphate

    Time frame: total proportion of patients receiving phosphate throughout 12-month study period

    Proportion of patients receiving any phosphate replacement

  3. Hospital Length of Stay

    Time frame: hospital admission to hospital discharge throughout 12-month study period

    Total time spent in hospital - hospital admission time to hospital discharge time

  4. Hospital Mortality

    Time frame: hospital admission to hospital discharge throughout 12-month study period

    hospital mortality rates for all participants throughout study period

  5. cardiac rhythm disturbance

    Time frame: ICU admission to ICU discharge, throughout 12-month study period

    Symptomatic cardiac rhythm disturbance (cardiac arrhythmia that requires treatment with chemical or electric cardioversion)

  6. Mechanical ventilation hours

    Time frame: hospital admission to hospital discharge, throughout 12-month study period

    Hours of invasive mechanical ventilation

  7. Tracheal reintubation

    Time frame: hospital admission to hospital discharge, throughout 12-month study period

    Tracheal intubation requirement during admission

Study contacts

Contact information is provided by the study sponsor or research team.

Emma L Williams

CONTACT

[email protected]

+61 488 474 254

Mahesh Ramanan

CONTACT

[email protected]

+61 7 5433 8888

Sponsors and collaborators

Lead sponsor

Caboolture Hospital

Other Gov

Collaborators

  • Queensland University of Technology

Registry information

Official study title

A Comparison of Two Phosphate Replacement Protocols for Critically Ill Patients Treated in an Intensive Care Unit: a Cluster, Crossover, Comparative Effectiveness, Randomised, Controlled Trial

Acronym: PROMPT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 17, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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