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Not yet recruiting NCT07288944

Protocolised Management of Phosphate Replacement Trial

No phase Interventional Phosphate Deficiency Hypophosphatemia Protocol Optimization Critical Care, Intensive Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liberal Phosphate Replacement Protocol, Restrictive Phosphate Replacement Protocol.
Who it may be relevant to
Registry conditions: Phosphate Deficiency, Hypophosphatemia, Protocol Optimization, Critical Care, Intensive Care. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Phosphate usage [Time frame: individual arm and total quantities used over 12-month study period]
  • Patients receiving phosphate [Time frame: total proportion of patients receiving phosphate throughout 12-month study period]
  • Hospital Length of Stay [Time frame: hospital admission to hospital discharge throughout 12-month study period]
  • Hospital Mortality [Time frame: hospital admission to hospital discharge throughout 12-month study period]
  • cardiac rhythm disturbance [Time frame: ICU admission to ICU discharge, throughout 12-month study period]
  • Mechanical ventilation hours [Time frame: hospital admission to hospital discharge, throughout 12-month study period]
  • Tracheal reintubation [Time frame: hospital admission to hospital discharge, throughout 12-month study period]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • There will be no specific exclusion criteria

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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
  • 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

Identifiers

NCT: NCT07288944 · HREC/2025/MNH/121108

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗