Protocolised Management of Phosphate Replacement Trial (PROMPT)

Caboolture Hospital

Status: Not yet enrolling

Conditions: Protocol Optimization; Hypophosphatemia; Phosphate Deficiency; Critical Care, Intensive Care

Treatments: Other: Restrictive Phosphate Replacement Protocol; Other: Liberal Phosphate Replacement Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT07288944

HREC/2025/MNH/121108

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There will be no specific exclusion criteria

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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2,400 participants in 2 patient groups

Liberal Phosphate Replacement Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Liberal Phosphate Replacement Protocol

Conservative Phosphate Replacement Protocol

Active Comparator group

Description:

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.

Treatment:

Other: Restrictive Phosphate Replacement Protocol