NCT07288944

Protocolised Management of Phosphate Replacement Trial

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: Caboolture Hospital · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Phosphate Deficiency
• Hypophosphatemia
• Protocol Optimization
• Critical Care, Intensive Care

Interventions

Type	Name	Description
OTHER	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.
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-02-01
• Completion: 2027-12-01
• First posted: 2025-12-17
• Last updated: 2025-12-17