Phosphate DeficiencyPROMPTNCT07288944
Protocolised Management of Phosphate Replacement Trial
A study testing Liberal Phosphate Replacement Protocol and Restrictive Phosphate Replacement Protocol in people with Phosphate Deficiency and Hypophosphatemia, run by Caboolture Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phosphate Deficiency, Hypophosphatemia, Protocol Optimization
- What is being tested?
- Liberal Phosphate Replacement Protocol and Restrictive Phosphate Replacement Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients admitted to participating intensive care units during the study period.
Who cannot join
- There will be no specific exclusion criteria
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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
- Being tested
- Liberal Phosphate Replacement Protocol, Restrictive Phosphate Replacement Protocol
- Keywords
- Phosphate Protocol, Critical Care, Intensive Care, Hypophosphatemia, Phosphate Deficiency
- Medical subject headings
- Hypophosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal Phosphate Replacement ProtocolOther
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 ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Restrictive Phosphate Replacement Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days post study enrolment
Secondary outcomes (7)
Phosphate usage
Quantities of intravenous and oral phosphate replaced (total and individually)
Measured: individual arm and total quantities used over 12-month study period
Patients receiving phosphate
Proportion of patients receiving any phosphate replacement
Measured: total proportion of patients receiving phosphate throughout 12-month study period
Hospital Length of Stay
Total time spent in hospital - hospital admission time to hospital discharge time
Measured: hospital admission to hospital discharge throughout 12-month study period
Hospital Mortality
hospital mortality rates for all participants throughout study period
Measured: hospital admission to hospital discharge throughout 12-month study period
cardiac rhythm disturbance
Symptomatic cardiac rhythm disturbance (cardiac arrhythmia that requires treatment with chemical or electric cardioversion)
Measured: ICU admission to ICU discharge, throughout 12-month study period
Mechanical ventilation hours
Hours of invasive mechanical ventilation
Measured: hospital admission to hospital discharge, throughout 12-month study period
Tracheal reintubation
Tracheal intubation requirement during admission
Measured: hospital admission to hospital discharge, throughout 12-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Phosphate DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Caboolture Hospital
- Sponsor type
- Other government
- Collaborators
- Queensland University of Technology
- Responsible party
- Sponsor
- Investigators
- Mahesh Ramanan, Principal investigator, +61 7 5433 8888
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288944
- Sponsor's protocol ID
- HREC/2025/MNH/121108
- Acronym
- PROMPT
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39685625Sin 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.
PubMed 33906104
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07288944
- Acronym / sponsor ID
- PROMPT / HREC/2025/MNH/121108
- Conditions
- Phosphate Deficiency, Hypophosphatemia, Protocol Optimization, Critical Care, Intensive Care
- Keywords
- Phosphate Protocol, Critical Care, Intensive Care, Hypophosphatemia, Phosphate Deficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Caboolture HospitalOther government
- Collaborators
- Queensland University of Technology
- Study start
- Jan 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Liberal Phosphate Replacement Protocol | Active comparator | Other: Liberal Phosphate Replacement ProtocolThe 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 | Active comparator | Other: Restrictive Phosphate Replacement ProtocolThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients admitted to participating intensive care units during the study period.
Key exclusion criteria (1 listed)
- There will be no specific exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liberal Phosphate Replacement ProtocolThe 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 |
| Restrictive Phosphate Replacement ProtocolThe 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 | Conservative Phosphate Replacement Protocol |
Primary outcome
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
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Background: PubMed 39685625Ramanan 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.
- Background: PubMed 33906104Sin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mahesh Ramanan principal investigator
+61 7 5433 8888
Questions about this trial
What is this clinical trial studying?
A study testing Liberal Phosphate Replacement Protocol and Restrictive Phosphate Replacement Protocol in people with Phosphate Deficiency and Hypophosphatemia, run by Caboolture Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mahesh Ramanan (+61 7 5433 8888, mahesh.ramanan@health.qld.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07288944, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.