None listed
Conditions
Brief summary
Phosphate is a very important electrolyte and, as such, low phosphate serum levels must be treated promptly. In the Intensive Care Unit (ICU) critically ill patients are at risk of low phosphate levels and phosphate ions are frequently administered via the enteral or parenteral (intravenous) route. There is little data on which route is best but there is a tenfold cost differential between the enteral and parental preparations. In addition, there may be more healthcare waste associated with the parenteral route. Given the potential but unproven advantages of the enteral route, this study aims compare the safety and effectiveness of phosphate replacement via the enteral and paraenteral routes.
Interventions
This study will compare two routes of phosphate replacement in critically ill patients with hypophosphatemia; enteral or paraenteral (intravenous). Both routes are current standard care.
Participants assigned to the 'enteral route' will receive phosphate tablets (500mg per tablet). The decision regarding single dose or regular (once, twice or three times per day) will be that of the treating physician and will be based on a variety of factors, including the severity of hypophosphatemia. The equ
This study will compare two routes of phosphate replacement in critically ill patients with hypophosphatemia; enteral or paraenteral (intravenous). Both routes are current standard care. Participants assigned to the 'enteral route' will receive phosphate tablets (500mg per tablet). The decision regarding single dose or regular (once, twice or three times per day) will be that of the treating physician and will be based on a variety of factors, including the severity of hypophosphatemia. The equivalent of 500mg of oral phosphate is 16.1mmol of phosphate. Additionally, there are 20.4mmol of sodium bicarbonate (350 mg) and 3.1mmol of potassium bicarbonate (315mg). Participants assigned 'parenteral route' will receive either sodium dihydrogen phosphate or potassium dihydrogen phosphate, or both, depending on the treating physician discretion. Similarly, this is guided by factors including serum sodium and potassium concentrations. The dose of phosphate will vary from 10 to 45mmol with maximal rate of administration of 20mmol per hour and decided by the intensive care (ICU) team. Medical records will be monitored frequently to ensure adherence to intervention arm.
Sponsors
Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All adult patients admitted to RMH ICU who require phosphate replacement with serum phosphate level <0.75mmol/l.
Exclusion criteria
- Serum phosphate concentration <0.3mmol/L, i.e., severe hypophosphatemia - Either enteral or parenteral replacement is not possible (i.e., no enteric feeding tube, intolerance of enteral feeding with gastric aspiration >300ml or no intravenous line) - Treating clinician believes that either enteral or parenteral phosphate replacement is indicated for this patient
Outcome results
None listed