Protocolised Management of Phosphate Replacement Trial

NCT07288944 | Not Yet Recruiting DMC

• 1 other identifier: HREC/2025/MNH/121108
• Study Type: interventional
• Target: 2,400
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Phosphate Protocol; Critical Care; Intensive Care; Hypophosphatemia; Phosphate Deficiency

Outcome Measures

Primary Outcomes (1)

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

  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.

  30 Days post study enrolment

Secondary Outcomes (7)

• Phosphate usage

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

• Patients receiving phosphate

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

• Hospital Length of Stay

  hospital admission to hospital discharge throughout 12-month study period

• Hospital Mortality

  hospital admission to hospital discharge throughout 12-month study period

• cardiac rhythm disturbance

  ICU admission to ICU discharge, throughout 12-month study period

Study Arms (2)

Liberal Phosphate Replacement Protocol

ACTIVE COMPARATOR

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: Liberal Phosphate Replacement Protocol

Conservative Phosphate Replacement Protocol

ACTIVE COMPARATOR

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.

Other: Restrictive Phosphate Replacement Protocol

Interventions

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.

Conservative Phosphate Replacement Protocol

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.

Liberal Phosphate Replacement Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Caboolture Hospital: lead
• Queensland University of Technology: collaborator

Related Publications (2)

• 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.

  PMID: 39685625 BACKGROUND

• 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.

  PMID: 33906104 BACKGROUND

MeSH Terms

Conditions

Hypophosphatemia

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mahesh Ramanan

  +61 7 5433 8888

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahesh Ramanan

CONTACT

+61 7 5433 8888; mahesh.ramanan@health.qld.gov.au

Emma L Williams

CONTACT

+61 488 474 254; emma.williams6@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 17, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share