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
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Caboolture Hospital
- Enrollment
- 2,400
- Primary Endpoint
- non-inferiority for days alive and free of the intensive care unit (ICU) up to 30 days (DAF-ICU-30)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 exclusion criteria
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Phosphate usage(individual arm and total quantities used over 12-month study period)
- Patients receiving phosphate(total proportion of patients receiving phosphate throughout 12-month study period)
- Hospital Length of Stay(hospital admission to hospital discharge throughout 12-month study period)
- Hospital Mortality(hospital admission to hospital discharge throughout 12-month study period)
- cardiac rhythm disturbance(ICU admission to ICU discharge, throughout 12-month study period)
- Mechanical ventilation hours(hospital admission to hospital discharge, throughout 12-month study period)
- Tracheal reintubation(hospital admission to hospital discharge, throughout 12-month study period)