Study Results
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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NOT_YET_RECRUITING
NA
2400 participants
INTERVENTIONAL
2026-01-31
2027-12-31
Brief Summary
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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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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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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
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.
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.
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Queensland University of Technology
OTHER
Caboolture Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Mahesh Ramanan
Role: PRINCIPAL_INVESTIGATOR
+61 7 5433 8888
Central Contacts
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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.
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.
Other Identifiers
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HREC/2025/MNH/121108
Identifier Type: -
Identifier Source: org_study_id