EnteraL rathEr thAn iNtravenous Electrolyte Replacement in critically ill patients (LEANER)
EnteraL rathEr thAn iNtravenous Electrolyte Replacement in critically ill patients (LEANER): A prospective, hybrid type I effectiveness implementation, stepped-wedge, cluster-randomised, non-inferiority, registry-based pragmatic trial to evaluate the effectiveness and acceptability of enteral rather than intravenous electrolyte replacement.
The University of Melbourne
1,344 participants
Nov 2, 2026
Interventional
Conditions
Summary
Critically ill patients in the ICU are commonly observed to have low serum electrolyte concentration of magnesium and/or phosphate. Prompt treatment must be administered to avoid serious harm. The intravenous (IV) route is most commonly administered in the ICU. This is important for very unwell patients in the ICU where electrolyte levels are dangerously low. However, most patients in the ICU have electrolyte levels that are only slightly or moderately low and we are exploring if the enteral route could be used more often. The enteral route has potential benefits - it costs less and produces less waste, therefore producing less carbon which makes it a more environmentally friendly alternative. There is little information known about how effective the enteral route is compared to IV for patients in the ICU, and whether the enteral route would be acceptable to staff and patients to use more often. This study is extending the work from two small clinical trials comparing enteral to IV route of magnesium and phosphate in the ICU. Both studies showed that enteral route didn’t cause harm, cost significantly less than the IV route and had less waste. However, there were mixed results on clinical effectiveness and wider testing in other ICUs is needed. In particular, staff perceptions of effectiveness, attitudes toward cost and environmental impact in decision making and beliefs on which route is “easier” to give have not been explored. The aim of this study is to test effectiveness of the enteral route compared to the IV route in a larger group of patients across multiple ICU settings. Each ICU will first use the IV route for all patients in the ICU that require electrolyte replacement for mild and moderately low electrolyte levels. We will then gradually ‘switch’ the ICUs across to using the enteral route. We will conduct staff surveys and group discussions to explore the factors that may influence staff in use of enteral or IV route.
Eligibility
Inclusion Criteria1
- All adult patients admitted to the ICU where the clinician wishes to prescribe electrolyte magnesium or phosphate replacement
Exclusion Criteria6
- Patients will be excluded because of:
- Age less then 18 years
- Severe life-threatening arrythmia requiring specific electrolyte treatment
- Either enteral or parenteral (IV) replacement is not possible or not required: No enteric feeding tube, intolerance of enteral feeding with aspiration of gastric contents (gastric residual volume) exceeding 500ml, clinician order to avoid enteral medication administration (eg. post gastrointestinal surgery), no intravenous access, able to swallow whole medication orally.
- Routine use of enteral magnesium or phosphate supplements prior to ICU admission.
- Pregnancy
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Interventions
This study will compare two routes of electrolyte replacement focusing on magensium and phosphate electrolytes. Critically ill patients in the ICU with either hypomagnesemia and/or hypophosphatemia will be adminstered electrolyte replacement either via the gut (enteral route) or via intravenous infusion (IV route). Both routes are current standard care. All doses will be prescribed per treating ICU clinician and will typically be prescribed as per standard ICU policy or guidelines. The decision on exact dose amount and frequency will be assessed for each individual patient, taking into consideration several factors such as the cause and severity of hypomagnesemia and/or hypophosphatemia. This trial is designed to be a pragmatic trial that reflects current standard prescribing and administration practice. Enteral dose magnesium: Magnesium aspartate dihydrate, 500 mg (equivalent to 37.4 mg or 1.55 mmol elemental magneium), 1-3 tablets TWO to THREE times daily, dissolved in water (typically 100ml) and administered via gastric tube. Enteral dose phosphate: Monophasic sodium phosphate, 500mg effervescent tablet (equivalent to 1.936 g monobasic sodium or 16 mmol) phosphate ions), 1 to 2 tablets BD - TDS dissolved in water (typically 100ml) and administered via gastric tube. The patient's medication chart in the medical record will be checked for administration of dose and route. ICU pharmacists will participate in weekly adherence checks during the intervention period. The pharmacists typically review patient medication charts daily and attend daily ICU ward rounds with medical and nursing staff. Hence are best placed to perform adherence checks. The weekly checks will be performed on one day, each week as a point of prevalence check. They will review all patients in the ICU on the day of the check for any electrolyte administered in previous 24hrs. Where the route was given against the cluster allocation (eg. IV instead of enteral) these will be recorded as protocol deviations. The pharmacists will also be able to provide ongoing education and reminders to staff in the ICU of the need to comply to cluster allocation of route wherever clincally appropriate to do so. A time and motion study will be embedded as a process evaluation in the trial. The aim of the trial and motion study will be to observe processes involved in prescribing and administering electrolyte replacement. An independent observer (research coordinator) will time medical staff on how long it takes and how many steps are performed (ie. click of the computer mouse) to navigate an electronic medication chart when prescribing an enteral and an IV dose of both magnesium and phosphate. In addition, nursing staff will be observed for preparation and administration of enteral and IV doses of magnesium and phosphate. Overall time taken will be recorded and a count of the number of individual steps to perform the administration task. A record will be documented of the type and number of consumables used during the administration task (ie. syringes, vials, IV fluid bags etc.). This information will be used in cost-effective and life cycle analyses.
Locations(1)
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ACTRN12626000623392