None listed
Conditions
Brief summary
Atrial Fibrillation (AF) is a type of heart rhythm disturbance which is relatively common in patients admitted to the Intensive Care Units (ICU) especially in people on breathing machines and/or who need drugs to support their blood pressure. Onset of fast AF (>130 beats/minute) in ICU is a clinical problem and usually associated with worsening clinical condition, low blood pressure, and poor outcome. The treatment of fast AF is variable and ranges from giving potassium or magnesium replacement or medications that slow down the heart's rate all the way up to providing an electric shock to "reset" the heart into a normal rhythm. Such invasive treatments are usually associated with significant side effects, and recognising ways to prevent fast AF could improve patient outcomes. Magnesium is also frequent in patients who are admitted to intensive care and I sbeleived to contribute to fast AF. Magnesium replacement via intermittent delivery via a drip in the patient’s vein is common practice in intensive care units. However, an optimal approach to replacing magnesium may be via continuous adminsotration via drip and may decrease the risk of fast AF. This study will aim to establish which of these two methods of administration of magnesium replacement in patients at risk of developing fast atrial fibrillation (AF) is better at preventing early AF in high risk patients.
Interventions
Study treatment is open-label intravenous magnesium loading of 10mmol diluted in 100 mL normal saline infused over 1 hour if the serum magnesium level <1.5mmol/L followed by continuous intravenous infusion of 3mmol/hr (10mmol Magsenium sulfate diluted in 100ml of normal saline) followed by an infusion to aim for an ionised Mg level of 0.9 to 1.3 mmol/L (total serum magnesium of 1.5 to 2 mmol/L).
If the baseline ionised Mg level is 0.9 to 1.3 mmol/L (total magnesium of 1.5 to 2 mmol/L), the con
Study treatment is open-label intravenous magnesium loading of 10mmol diluted in 100 mL normal saline infused over 1 hour if the serum magnesium level <1.5mmol/L followed by continuous intravenous infusion of 3mmol/hr (10mmol Magsenium sulfate diluted in 100ml of normal saline) followed by an infusion to aim for an ionised Mg level of 0.9 to 1.3 mmol/L (total serum magnesium of 1.5 to 2 mmol/L). If the baseline ionised Mg level is 0.9 to 1.3 mmol/L (total magnesium of 1.5 to 2 mmol/L), the continuous intravenous infusion will start without the loading dose. The study treatment will be delivered until one of the following occurs: 1. Vasoactive therapy and mechanical ventilation have been stopped 2. Four days have passed since start of treatment 3. Discharge from ICU 4. Onset of severe oliguria (<0.5 ml/kg/hr for 12 hours) or significant new renal dysfunction (a 50% increase in baseline serum creatinine) 5. Death Each study ICU will use the method of administration for magnesium therapy for six months. At the end of these six months, the ICU will then swap to the other routine administration method for the next six months. Study treatment will only be administered in situations where the treating clinician believes magnesium treatment is required to assist with the optimisation of magnesium levels. There will be no other recommended changes in management. Day-to-day management and assessment of electrolyte replacement will be up to the treating clinician. A flowchart regarding the administration of Magnesium will be provided at the bedside to guide the intervention protocol. Pre-printed blood tests will be provided for the appropriate dosage adjustment. A subsequent audit of bedside charts to confirm adherence to the intervention protocol.
Sponsors
Prof Rinaldo Bellomo
Study design
Allocation
Non-randomised 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
Patients who are invasively mechanically ventilated and receiving vasoactive agents.
Exclusion criteria
1. Patients who are allergic to the allocated trial drug. 2. Patients who have undergone cardiac surgery. 3. Pre-eclampsia, eclampsia, or post-partum hypertension. 4. Patients who are known to have atrial fibrillation. 5. Patients with severe Chronic Kidney Disease (eGFR<30ml/min). 6. Patients who Have severe oliguria (<0.5 ml/kg/hr for 12 hours) 7. Patients with serum total Magnesium level of < 0.4mmol/l.
Outcome results
None listed