About this trial
In patients with critical illness, such as severe infections, heart attacks, or respiratory failure, most intensive care units (ICUs) measure magnesium levels and give supplemental doses of magnesium when levels are below certain targets. However, the best targets are unknown. The goal of this clinical trial is to study protocols for magnesium supplementation in people with critical illness, comparing a protocol with higher target level to a protocol with a lower target level.
The main question this study aims to answer is whether magnesium supplementation protocols targeting a higher or lower level lead to better 30-day survival and less atrial fibrillation.
Participants will not have to do any specific tasks, undergo any additional tests, or complete any surveys.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 16 years or older
Admission orders written to a medical-surgical intensive care unit at a participating site
Magnesium replacement protocol ordered
Disqualifiers
Prior enrollment in or withdrawal from MAGNOLIA trial
Sustained ventricular tachycardia
Pre-eclampsia
Myasthenia gravis
Trial design
Parallel
Treatments tested in this trial
Magnesium sulfate administration
DrugMagnesium sulfate is used in both arms for magnesium replacement.
Magnesium oxide
DrugIn the higher-target arm, magnesium oxide 420mg po q12h x 2 is one of the options available for magnesium replacement when magnesium levels lie between 0.75 and 0.95mmol/L.
Magnesium glucoheptonate
DrugMagnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.
Treatment groups
Trial outcomes
Primary outcomes
30-day ordinal composite of hospital mortality and days free of atrial fibrillation in ICU
This is an ordinal outcome with 32 levels ranging from -1 (worst) to 30 (best). It is evaluated at 30 days. The worst outcome (-1) corresponds to mortality in hospital within 30 days from trial enrollment. Among patients who do not die in hospital by day 30, we count the number of days when they did not have atrial fibrillation in the ICU. For example, a survivor who never had atrial fibrillation in ICU would be scored as "30." A survivor who had 5 days of atrial fibrillation in ICU would be scored as "25." A patient who is discharged from hospital, either to home or transferred to another site, but is readmitted to a study hospital and dies within 30 days of enrollment, would be counted as having had hospital mortality. This stipulation is relevant because of the frequency of transfers between sites within a health network, due to regionalization of services such as vascular surgery, thoracic surgery, dialysis, and angiography.
Secondary outcomes
Organ-support free days
Number of days alive and free of invasive ventilation, vasopressors, and renal replacement therapy
ICU-free days
Number of days alive and not in ICU
Invasive ventilation-free days
Number of days alive and free of invasive ventilation
Vasopressor-free days
Days alive and not receiving vasopressors
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Scarborough General Hospital
Lead sponsor
Scarborough Health Network
Collaborator
Lakeridge Health Corporation
Collaborator