None listed
Conditions
Brief summary
Magnesium is a crucial electrolyte and low serum magnesium concentrations must be treated promptly to avoid adverse effects. In the intensive care unit, critically ill patients are at risk of low magnesium concentrations magnesium ions are frequently administered via the enteral or parenteral (intravenous) route. There is sparse data as to which route to use but there is likely to be at least a tenfold cost differential between the enteral and parental preparations. In addition, there may be more waste and subsequent environmental impact associated with parenteral route. Given the potential but unproven advantages of the enteral route we wish to compare the safety and effectiveness of magnesium replacement via the enteral route and parenteral routes.
Interventions
This study will compare two routes of magnesium replacement in critically ill patients with hypomagnesemia; enteral or parenteral (intravenous). Both routes are current standard care.
Those assigned enteral route will receive either Mag-sup (magnesium aspartate dihydrate tablets) 500mg per tablet, which is equivalent to 37.4 mg or 1.55 mmol of elemental magnesium, or Blackmores BIO MAGNESIUM (magnesium-calcium-vit B6-vit D3) tablets (300mg of elemental magnesium or 12.5 mmol per tablet). The de
This study will compare two routes of magnesium replacement in critically ill patients with hypomagnesemia; enteral or parenteral (intravenous). Both routes are current standard care. Those assigned enteral route will receive either Mag-sup (magnesium aspartate dihydrate tablets) 500mg per tablet, which is equivalent to 37.4 mg or 1.55 mmol of elemental magnesium, or Blackmores BIO MAGNESIUM (magnesium-calcium-vit B6-vit D3) tablets (300mg of elemental magnesium or 12.5 mmol per tablet). The decision regarding single dose or regular (once, twice or three times per day) will be decided by the treating physician who will make their decision considering several factors including the severity of hypomagnesemia. Those assigned the parenteral route will receive magnesium sulfate, where the dose of magnesium will vary from 10 to 20 mmol and depend on decision by the ICU clinician. The magnesium sulfate is diluted in 100 ml of 0.9% saline and administered over a minimum of one hour. 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 the RMH ICU who require magnesium replacement with serum magnesium level of <0.7 mmol/L
Exclusion criteria
- Serum magnesium concentration <0.7 mmol/l and new cardiac arrhythmia; or serum magnesium concentration less than or equal to 0.35 mmol/l (ie., severe hypomagnesemia) - Either enteral or parenteral replacement is not possible (ie., no enteric feeding tube, intolerance of enteral feeding with gastric aspiration >300ml or no intravenous line) - Treating clinician believes that either enteral or parenteral magnesium is indicated for this patient -Patient's currently having enteral magnesium replacement order
Outcome results
None listed