Protocolised Management of Phosphate Replacement Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCaboolture Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All adult patients admitted to participating intensive care units during the study period.
Disqualifiers
There will be no specific exclusion criteria
Trial design
Design model
Crossover
Treatments tested in this trial
Liberal Phosphate Replacement Protocol
Other interventionThe 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 Protocol
Other interventionThe 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.
Treatment groups
2,400 Participants
are divided into 2 treatment groupsGroup A: Liberal Phosphate Replacement ProtocolActive comparator 1 intervention
Group B: Conservative Phosphate Replacement ProtocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
30 Days post study enrolmentSecondary outcomes
1
Phosphate usage
Quantities of intravenous and oral phosphate replaced (total and individually)
Time frame
individual arm and total quantities used over 12-month study period2
Patients receiving phosphate
Proportion of patients receiving any phosphate replacement
Time frame
total proportion of patients receiving phosphate throughout 12-month study period3
Hospital Length of Stay
Total time spent in hospital - hospital admission time to hospital discharge time
Time frame
hospital admission to hospital discharge throughout 12-month study period4
Hospital Mortality
hospital mortality rates for all participants throughout study period
Time frame
hospital admission to hospital discharge throughout 12-month study periodLocations
Sponsors and contacts
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Caboolture Hospital
Lead sponsor
Queensland University of Technology
Collaborator
Source ClinicalTrials.gov
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