Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age16+
SponsorScarborough General Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Magnesium sulfate administration

    Drug

    Magnesium sulfate is used in both arms for magnesium replacement.

  • Magnesium oxide

    Drug

    In 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

    Drug

    Magnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.

Treatment groups

3,853 Participants
are divided into 2 treatment groups
Group A: Lower target (>0.7mmol)Other 1 intervention
Group B: Higher target (>0.95mmol/L)Other 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
30 days after enrollment.

Secondary outcomes

1

Organ-support free days

Number of days alive and free of invasive ventilation, vasopressors, and renal replacement therapy

Time frame
30 days
2

ICU-free days

Number of days alive and not in ICU

Time frame
30 days
3

Invasive ventilation-free days

Number of days alive and free of invasive ventilation

Time frame
30 days
4

Vasopressor-free days

Days alive and not receiving vasopressors

Time frame
30 days

Other outcomes

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