Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Queensland University of Technology | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Phosphate usage | Quantities of intravenous and oral phosphate replaced (total and individually) | individual arm and total quantities used over 12-month study period |
| Patients receiving phosphate |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Mahesh Ramanan | +61 7 5433 8888 | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39685625 | Background | 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. | |
| 33906104 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017674 | Hypophosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
| 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. |
|
Proportion of patients receiving any phosphate replacement
| 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 | hospital admission to hospital discharge throughout 12-month study period |
| Hospital Mortality | hospital mortality rates for all participants throughout study period | 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) | ICU admission to ICU discharge, throughout 12-month study period |
| Mechanical ventilation hours | Hours of invasive mechanical ventilation | hospital admission to hospital discharge, throughout 12-month study period |
| Tracheal reintubation | Tracheal intubation requirement during admission | hospital admission to hospital discharge, throughout 12-month study period |