Magnesium Replacement for Critical Illness

(MAGNOLIA Trial)

Not yet recruiting at 4 trial locations

Overseen By Joshua Craig

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Scarborough General Hospital

Disqualifiers: Ventricular tachycardia, Pre-eclampsia, Myasthenia gravis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of administering magnesium to intensive care patients with severe infections or heart issues. Doctors frequently monitor magnesium levels and provide supplements, but the optimal target remains unclear. The trial compares a higher magnesium target to a lower one to determine which improves survival and reduces atrial fibrillation (an irregular heartbeat). Intensive care patients with a magnesium replacement protocol may be suitable candidates for this trial. Participants will not need to perform additional tasks or undergo extra tests. As a Phase 4 trial, this research aims to understand how an already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for magnesium supplementation protocols?

Research has shown that giving magnesium to very sick patients is generally safe. Studies have found that patients taking magnesium supplements often experience fewer kidney problems, indicating their bodies handle the treatment well. In one study, very sick patients with low magnesium levels received supplements, and no major safety issues arose.

Hospitals commonly use magnesium for various health issues, making it a well-known treatment. Some patients might experience mild side effects, such as loose stools, but serious problems are rare. Since this trial is in a late stage, extensive safety information suggests that the treatment is likely well-tolerated in people. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the Magnesium Replacement for Critical Illness trial because it explores how different magnesium levels might impact recovery for critically ill patients. Unlike standard care, which often involves general electrolyte management without specific magnesium targeting, this trial investigates precise magnesium level adjustments. The trial uses targeted magnesium supplementation, such as magnesium sulfate, magnesium oxide, and magnesium glucoheptonate, to achieve specific blood magnesium levels. By tailoring magnesium replacement to individual needs, researchers hope to improve patient outcomes more effectively than traditional methods.

What evidence suggests that this trial's magnesium supplementation protocols could be effective for critical illness?

Research has shown that magnesium supplementation can benefit very sick patients. Studies have found that ICU patients with low magnesium levels often improve when their magnesium levels increase. Evidence suggests that adding magnesium can reduce the risk of sudden kidney problems and improve survival chances. In some cases, it may also help prevent atrial fibrillation, an irregular heartbeat. This trial compares different magnesium levels, with one arm targeting a lower level (>0.7 mmol) and another targeting a higher level (>0.95 mmol), to determine the best outcomes for patients. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for critically ill patients in ICUs with conditions like severe infections, heart attacks, or respiratory failure. They must be undergoing routine magnesium level checks and require supplementation. There's no mention of specific exclusion criteria provided.

Inclusion Criteria

I am admitted to the ICU at a participating hospital.

I am 16 years old or older.

I am on a magnesium replacement plan.

Exclusion Criteria

Pre-eclampsia

Prior enrollment in or withdrawal from MAGNOLIA trial

I have myasthenia gravis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Integrated with EMR

Treatment

Protocolized magnesium replacement with higher or lower target levels in critically ill patients

30 days

Embedded in routine ICU care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hospital mortality and atrial fibrillation outcomes

60-90 days

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium

Trial Overview The study compares two magnesium supplementation protocols in the ICU: one aims for a higher blood magnesium target (>0.95mmol/L), while the other aims for a lower target (>0.7mmol/L). It looks at which protocol better improves survival rates and reduces atrial fibrillation within 30 days.

How Is the Trial Designed?

Group I: Lower target (>0.7mmol) Experimental Treatment 1 Intervention

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.

Group II: Higher target (>0.95mmol/L) Experimental Treatment 3 Interventions

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.

Who Is Running the Clinical Trial?

Scarborough General Hospital

Lead Sponsor

Trials

11

Recruited

6,500+

Scarborough Health Network

Collaborator

Lakeridge Health Corporation

Collaborator

Trials

7

Recruited

6,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07173855

Effect of Protocolized Magnesium Replacement on ... The goal of this clinical trial is to study protocols for magnesium supplementation in people with critical illness, comparing a protocol with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28703019/

Effectiveness and Safety of Magnesium Replacement in ... This study's purpose was to evaluate the effectiveness and safety surrounding magnesium replacement in medically, critically ill patients with mild-to-moderate ...

3. withpower.com withpower.com/trial/phase-4-critical-illness-10-2025-630d5

Magnesium Replacement for Critical Illness (MAGNOLIA ... The goal of this clinical trial is to study protocols for magnesium supplementation in people with critical illness, comparing a protocol with higher target ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9728415/

A prospective observational study to identify the effectiveness ... Results: In total, 27.27% of patients admitted in our intensive care unit had an incidence of hypomagnesemia. The average rise of serum magnesium levels in ...

5. bjanaesthesia.org.uk bjanaesthesia.org.uk/article/S0007-0912(23)00435-X/fulltext

a retrospective propensity score-matched cohort study Trials have demonstrated lower rates of acute kidney injury in critically ill patients receiving magnesium supplementation, but they have ...