ClinicalTrials.gg
RecruitingNCT07173855MAGNOLIAUpdated Sep 24, 2026

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

A Phase 4 interventional study of Magnesium sulfate administration and Magnesium oxide in Critical Illness, sponsored by Scarborough General Hospital. Recruiting at 6 sites in Canada. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Primary conditionAtrial FibrillationRegistry: Critical IllnessReclassifiedWhy we changed it
Registry
Critical Illness — the first condition term the registry derived for this study.
ClinicalTrials.gg
Atrial Fibrillation
Why
  1. Critical Illness is a broad heading, used only when no more specific condition is named.
  2. The study's title name Atrial Fibrillation.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Scarborough General Hospital · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
3,853
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 318 studies in Atrial Fibrillation with a site in Canada — 50 open to participants now, 73 under way, 8 of them phase 3. Atrial Fibrillation · Canada.

Planned enrollment
20th of 261
3,853 · median 282
Started
2025
with 9 others
Phase 4
30 of 318
3 open now
Primary completion
2027-03
later than 30 of 72 live
Registered
307th of 318
by date

Among the 318 studies in Atrial Fibrillation with a site in Canada, this one is the 20th largest by planned enrollment of the 261 interventional ones that give a count, is one of 10 that started in 2025, is one of 30 in phase 4, reaches primary completion later than 30 of the 72 other live ones, and was the 307th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

50 of the 318 studies in Atrial Fibrillation with a site in Canada are open now. Recruiting first, the newest first:

44 more — sign in →

All 50 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 612 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 44 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 16 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 318 studies in Atrial Fibrillation with a site in Canada, or all of them as a file.
02

Study summary

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.

Read the 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.

03

Conditions studied

  • Critical Illness

Browse trials for

Keywords

  • Critical illness
  • Magnesium
  • Atrial fibrillation
  • Protocols
04

In context

Atrial Fibrillation Reclassified

4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.

This study's planned enrollment of 3,853 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

Scarborough General Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Compared within Atrial Fibrillation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Prior enrollment in or withdrawal from MAGNOLIA trial
  • Sustained ventricular tachycardia
  • Pre-eclampsia
  • Myasthenia gravis
06

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,853 participants (estimated)

Study arms

  • Other
    Lower target (>0.7mmol)

    Protocolized magnesium replacement according to magnesium level as follows: for 0.45 - 0.70mmol/L, magnesium sulfate 4g IV x 1 and repeat magnesium level the next day; for \< 0.45mmol/L, magnesium sulfate 6g IV x 1, alert most responsible physician, and repeat level in 4 hours.

    Drug: Magnesium sulfate administration

  • Other
    Higher target (>0.95mmol/L)

    Protocolized magnesium replacement according to magnesium level as follows: for 0.75-0.95mmol/L, magnesium sulfate 2g IV x 1, magnesium oxide 420 mg po q12h x 2, or magnesium glucoheptonate 30mL po q12h x 2; for 0.45 - 0.74mmol/L, magnesium sulfate 4g IV x 1 and repeat magnesium level the next day; for \< 0.45mmol/L, magnesium sulfate 6g IV x 1, alert most responsible physician, and repeat level in 4 hours.

    Drug: Magnesium sulfate administration · Drug: Magnesium oxide · Drug: Magnesium glucoheptonate

Interventions

  • DrugMagnesium sulfate administration

    Magnesium sulfate is used in both arms for magnesium replacement.

  • 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.

  • DrugMagnesium glucoheptonate

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

07

What researchers measure

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

  5. Renal replacement therapy-free days

    Days alive and not receiving renal replacement therapy in the ICU

    Time frame: 30 days

  6. Ventricular arrhythmia

    Binary outcome noting the occurence of either sustained ventricular tachycardia or ventricular fibrillation in ICU (1), or not (0).

    Time frame: 30 days

  7. Intravenous antiarrhythmics

    Binary variable noting administration of intravenous antiarrhythmics in ICU (1) or not (0). Intravenous antiarrhythmics include amiodarone, metoprolol, esmolol, diltiazem, procainamide, lidocaine, flecainide, adenosine, digoxin.

    Time frame: 30 days

  8. Magnesium and potassium levels in ICU

    Daily levels of magnesium and potassium in ICU

    Time frame: 30 days

  9. Magnesium administrations

    Magnesium administrations while in ICU (number per day)

    Time frame: 30 days

  10. Fluid balance

    Daily fluid balance (sum of all liquid intakes minus the sum of all liquid outputs).

    Time frame: 30 days

  11. DOOR 1: Death and arrhythmia

    This is a desirability of outcome ordinal ranking (DOOR) outcome. The possible binary levels are, from worst to best: death, ventricular arrhythmia, atrial fibrillation or flutter, none of the above.

    Time frame: 30 days

  12. DOOR 2: Survival, organ dysfunction, hospitalization, discharge

    This is a desirability of outcome ordinal ranking (DOOR) outcome. The binary levels are, ordered from best to worst: discharge home, discharge to location other than home, ongoing hospital admission, persistent organ dysfunction in ICU, death.

    Time frame: 30 days

  13. Hospital mortality

    Hospital mortality

    Time frame: 60 days

  14. Hospital mortality

    Hospital mortality

    Time frame: 90 days

  15. Hospital length of stay

    Length of hospitalization, including transfers within the health network.

    Time frame: 90 days

  16. Discharge destination

    Categorical variable noting discharge destination on index hospitalization (eg home, retirement home, long-term care, acute care hospital, etc).

    Time frame: 90 days

  17. Magnesium administrations - by mass

    Elemental magnesium administered (g per day)

    Time frame: 30 days

  18. Magnesium administrations - route

    Route of magnesium administrations each day (PO vs IV)

    Time frame: 30 days

08

Study locations

6 of 6 sites recruiting
  • Lakeridge Health Ajax-Pickering
    Ajax, Ontario L1S 2J4, Canada
    Recruiting
  • Lakeridge Health Bowmanville
    Bowmanville, Ontario L1C 2N3, Canada
    Recruiting
  • Lakeridge Health Oshawa
    Oshawa, Ontario L1G 8A2, Canada
    Recruiting
  • Scarborough Centenary Hospital
    Toronto, Ontario M1E 4B9, Canada
    Recruiting
  • Scarborough General Hospital
    Toronto, Ontario M1P2V5, Canada
    Recruiting
  • Scarborough Birchmount Hospital
    Toronto, Ontario M1W 3W3, Canada
    Recruiting
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Deidentified data will be posted in the Health Data Nexus (https://healthdatanexus.ai/) deidentified data repository overseen by the University of Toronto Temerty Centre for Artificial Intelligence Research and Education in Medicine. This will allow credentialed access to deidentified individual patient data.

Supporting information: Study protocol

Time frame: Deidentified data will be posted in the Health Data Nexus repository after publication of the primary trial results.

Access criteria: Credentialed access to the Health Data Nexus is available to anyone who fulfills the requirements, including an ethics course (TCPS2 2022) and signing a data use agreement.

Data sharing details ↗ · healthdatanexus.ai

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.

Of 129 non-industry phase 4 interventional studies under Atrial Fibrillation, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 81. This study's planned 15 months is below that.

Counting every sponsor, half of 141 studies reached it within 48 months; a quarter within 27 and three quarters within 81.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2025
First posted
Sep 15, 2025
StartActual
Nov 25, 2025
Primary completionEst.
Mar 1, 2027
CompletionEst.
Jun 1, 2027
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07173855
Lead sponsor
Scarborough General Hospital
Collaborators
Scarborough Health Network, Lakeridge Health Corporation
Responsible party
Christopher Yarnell (Intensivist and Researcher, Scarborough General Hospital) — Principal investigator
First posted
Sep 15, 2025
Start date
Nov 25, 2025
Primary completion
Mar 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Sep 24, 2026

Study contacts

Joshua Craig
Contact
jcraig@shn.ca
4164382911 ext. 86006

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Magnesium Oxide

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