Critical Care, Intensive Care, Hypophosphatemia, Phosphate Deficiency, Protocol Optimization
Conditions
Keywords
Phosphate Protocol, Critical Care, Intensive Care, Hypophosphatemia, Phosphate Deficiency
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.
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
OTHERLiberal 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.
OTHERRestrictive 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.
Sponsors
Queensland University of Technology
Caboolture Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All adult patients admitted to participating intensive care units during the study period.
Exclusion criteria
* There will be no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| non-inferiority for days alive and free of the intensive care unit (ICU) up to 30 days (DAF-ICU-30) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients receiving phosphate | total proportion of patients receiving phosphate throughout 12-month study period | Proportion of patients receiving any phosphate replacement |
| Hospital Length of Stay | hospital admission to hospital discharge throughout 12-month study period | Total time spent in hospital - hospital admission time to hospital discharge time |
| Hospital Mortality | hospital admission to hospital discharge throughout 12-month study period | hospital mortality rates for all participants throughout study period |
| Phosphate usage | individual arm and total quantities used over 12-month study period | Quantities of intravenous and oral phosphate replaced (total and individually) |
| Mechanical ventilation hours | hospital admission to hospital discharge, throughout 12-month study period | Hours of invasive mechanical ventilation |
| Tracheal reintubation | hospital admission to hospital discharge, throughout 12-month study period | Tracheal intubation requirement during admission |
| cardiac rhythm disturbance | ICU admission to ICU discharge, throughout 12-month study period | Symptomatic cardiac rhythm disturbance (cardiac arrhythmia that requires treatment with chemical or electric cardioversion) |
Contacts
Primary ContactMahesh Ramanan
Backup ContactEmma L Williams
Outcome results
None listed