None listed
Conditions
Brief summary
Derangements of serum phosphate concentrations, specifically hypophosphataemia, are common among ICU patients and our previous work has suggested this may be associated with worse clinical outcomes, including higher mortality and morbidity. Although replacement of phosphate through both intravenous and enteral routes is common in ICUs, the optimum threshold of serum phosphate at which to commence active replacement in critically ill patients is currently unknown, and the benefits have never been confirmed with an RCT. Resultantly, there are no consensus guidelines on phosphate replacement in ICU, with individual ICUs and clinicians self determining thresholds at which to replace phosphate. Such treatment comes at significant cost and there are potential adverse outcomes associated with phosphate replacement including hypocalcaemia (potentially precipitous and life-threatening), nausea, vomiting, diarrhoea and hypotension. Thus, ICU clinicians are left with substantial uncertainty about the optimal threshold at which to replace phosphate. Therefore, a clinical and ethical imperative exists to conduct a high-quality, investigator initiated, RCT to inform clinical practice with regards to phosphate replacement and its impacts on patient centred outcomes in critically ill patients. The PRICE-1 RCT will compare the use of a restrictive phosphate replacement protocol against a liberal phosphate replacement protocol for the management of serum phosphate levels in critically ill patients. The liberal protocol will start replacing phosphate when the serum concentration is below 0.80 mmol/L, whereas the restrictive protocol will start replacement when the serum phosphate concentration is below 0.50 mmol/L. The choice of oral versus intravenous phosphate administration is determined by the functioning of the patient's gastrointestinal tract. All other aspects of patient care will be determined by the treating clinicians as is appropriate for the condition/s with which the patients are admitted to the Intensive Care Unit. We hypothesise that use of a restrictive phosphate replacement protocol, compared to a liberal protocol, will result in reduced amount of phosphate replacement administered to critically ill patients in the Intensive Care Unit. Additionally, we hypothesise that the conduct of an electronic database-integrated cluster randomised trial will be feasible.
Interventions
Three ICUs will be randomised to use either the restrictive or liberal phosphate replacement protocol for a three-month period, followed by a one-month washout period. The sites will then crossover to the alternate phosphate replacement protocol for another three-month period.
For the duration of the trial, all patients admitted to participating ICUs will have phosphate replacement delivered as per the study-allocated phosphate replacement protocol. Clinicians may determine whether oral or intr
Three ICUs will be randomised to use either the restrictive or liberal phosphate replacement protocol for a three-month period, followed by a one-month washout period. The sites will then crossover to the alternate phosphate replacement protocol for another three-month period. For the duration of the trial, all patients admitted to participating ICUs will have phosphate replacement delivered as per the study-allocated phosphate replacement protocol. Clinicians may determine whether oral or intravenous replacement should be administered, as well as the dose and frequency of replacement. The PRICE-1 trial will only stipulate the threshold at which phosphate replacement may be initiated. The restrictive protocol will stipulate phosphate replacement to commence at a threshold of 0.50 mmol/L, and the liberal protocol at 0.80 mmol/L. All other treatment will be at the discretion of the treating clinician. During the first study period, the three participating ICUs will be randomised to either the restrictive or liberal phosphate replacement protocol. At the completion of the first study period (i.e., after three months), there will be a one-month washout period. For the second study period, the ICUs will crossover to the alternate phosphate replacement protocol i.e., if ICU-A used the restrictive protocol for the first study period, it will crossover to the liberal protocol for the second study period, and vice versa. The use of the allocated protocol and adherence to the protocol will be monitored using electronic medical records.
Sponsors
The PRICE-1 Trial Investigators
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All patients admitted to the participating ICUs during the study period
Exclusion criteria
1) Patients admitted solely for provision of palliative care or awaiting organ donation 2) Patients who have already been included in the PRICE-1 trial (i.e., only the first ICU admission for each patient during the trial will be eligible for inclusion in the trial)
Outcome results
None listed