Effect of Protocolized Magnesium Replacement on Mortality and Atrial Fibrillation in Critically Ill Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium sulfate administration, Magnesium oxide, Magnesium glucoheptonate.
- Who it may be relevant to
- Registry conditions: Critical Illness. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Protocolized Magnesium Replacement in Critically Ill Patients on Mortality and Atrial Fibrillation: the MAGNOLIA Randomized Controlled Trial
Overview
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.
Detailed description
Background: Measurement of serum magnesium levels, and administration of supplemental magnesium when levels are below target, is a common element of routine care for critically ill patients. However, targets for replacement vary, and the targets that lead to the best outcomes are unknown.
Methods: Multi-center open-label parallel group randomized controlled superiority trial of adult critically ill patients receiving protocolized magnesium replacement, comparing a higher target (\>0.95mmol/L) to a lower target (\>0.7mmol/L). The trial will be embedded into the electronic medical record (EMR) at 5 hospitals across 2 health networks in Ontario, Canada, with a shared EMR. Patients aged 16 years or older who have ICU admission orders and an order for the magnesium replacement protocol will be included. Patients with pre-eclampsia, sustained ventricular tachycardia, or neuromuscular junction disease will be excluded. The primary outcome will be an ordinal composite, evaluated at 30 days, composed of death and the number of days free of atrial fibrillation or flutter in ICU. Secondary outcomes will include ventricular arrhythmia and antiarrhythmics administered; receipt of vasopressors, ventilation, and new renal replacement therapy in ICU; lengths of ICU and hospital stay; hospital mortality at 60 and 90 days, magnesium levels, and magnesium supplementation. Analyses will use Bayesian regression with weakly skeptical priors and an intention-to-treat approach. Because both targets lie within the standard of care, the trial will use opt-out consent. Screening will be integrated with the EMR, such that when a patient meets inclusion criteria, a pop-up will appear for the ordering clinician. After the clinician confirms eligibility, the patient will be randomized and assigned to their target. Outcome ascertainment will occur within the EMR.
Discussion: This randomized controlled trial addresses an important uncertainty regarding routine care in the ICU with an EMR-embedded design. The innovative EMR-embedded design facilitates the large sample sizes and comprehensive, equitable recruitment needed for a trial evaluating a routine care intervention, and will lead to seamless integration with routine care upon trial completion.
Interventions
- Drug Magnesium sulfate administration
Magnesium sulfate is used in both arms for magnesium replacement. - Drug Magnesium oxide
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. - Drug Magnesium glucoheptonate
Magnesium glucoheptonate 30mL po q12h x 2 is an oral option for magnesium replacement in the higher-target arm.
Primary outcome measures
- 30-day ordinal composite of hospital mortality and days free of atrial fibrillation in ICU [Time frame: 30 days after enrollment.]
Secondary outcome measures (12)
- Organ-support free days [Time frame: 30 days]
- ICU-free days [Time frame: 30 days]
- Invasive ventilation-free days [Time frame: 30 days]
- Vasopressor-free days [Time frame: 30 days]
- Renal replacement therapy-free days [Time frame: 30 days]
- Ventricular arrhythmia [Time frame: 30 days]
- Intravenous antiarrhythmics [Time frame: 30 days]
- Magnesium and potassium levels in ICU [Time frame: 30 days]
- Magnesium administrations [Time frame: 30 days]
- Fluid balance [Time frame: 30 days]
- DOOR 1: Death and arrhythmia [Time frame: 30 days]
- DOOR 2: Survival, organ dysfunction, hospitalization, discharge [Time frame: 30 days]
Eligibility criteria
Inclusion criteria
- Age 16 years or older
- Admission orders written to a medical-surgical intensive care unit at a participating site
- Magnesium replacement protocol ordered
Exclusion criteria
- Prior enrollment in or withdrawal from MAGNOLIA trial
- Sustained ventricular tachycardia
- Pre-eclampsia
- Myasthenia gravis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 6 centers
- Lakeridge Health Ajax-Pickering — Ajax
- Lakeridge Health Bowmanville — Bowmanville
- Lakeridge Health Oshawa — Oshawa
- Scarborough Centenary Hospital — Toronto
- Scarborough General Hospital — Toronto
- Scarborough Birchmount Hospital — Toronto
Identifiers
NCT: NCT07173855 · ICU-25-018