130 Participants Needed

Magnesium Sulfate for Mesothelioma

(MAGIC-AKI Trial)

SG
Overseen ByShruti Gupta, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are participating in another study with an experimental therapy that might interact with IV magnesium, you may not be eligible.

Is magnesium sulfate safe for use in humans?

Magnesium sulfate is generally considered safe for use in humans, especially in obstetrics for conditions like eclampsia, with a low incidence of toxicity. However, there is a risk of accidental overdose, which can be harmful, so careful monitoring is necessary.12345

How does the drug Magnesium Sulfate differ from other treatments for mesothelioma?

Magnesium Sulfate is unique for mesothelioma treatment as it is not a standard therapy for this condition, and its use is being explored for its potential benefits, unlike traditional chemotherapy or radiation treatments.678910

What is the purpose of this trial?

In this research study, investigators will test whether prophylactic high-dose IV Mg administration attenuates the risk of AKI in patients with malignant mesothelioma receiving intraoperative chemotherapy (HIOC) with cisplatin compared to placebo.

Research Team

DE

David E. Leaf, MD, MMSc

Principal Investigator

Brigham and Women's Hospital

SG

Shruti Gupta, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with malignant mesothelioma who are undergoing surgery with HIOC. Participants must be treated by Dr. Raphael Bueno or another BWH thoracic surgeon and have normal kidney function. It's not for those with slow heart rates, recent COVID, severe heart block without a pacemaker, pregnant/breastfeeding women, certain neuromuscular diseases, prisoners, magnesium allergy or high serum magnesium levels.

Inclusion Criteria

I am an adult with mesothelioma planning surgery with HIOC at BWH.

Exclusion Criteria

Conflict with other study
I am not in a study that could affect my IV magnesium treatment.
I have had significant heart artery blockage or surgery for it in the last year.
See 10 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive either high-dose IV magnesium or placebo during surgery with HIOC

1 day
Intraoperative administration

Immediate Postoperative Monitoring

Participants are monitored for serum magnesium levels and other secondary outcomes

2 days
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of AKI and other outcomes

7 days
Daily monitoring

Treatment Details

Interventions

  • Magnesium Sulfate
Trial Overview The study is testing if giving high-dose IV Magnesium can reduce the risk of AKI in patients getting intraoperative chemotherapy with cisplatin for mesothelioma compared to a placebo (Normal Saline).
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Magnesium SulfateExperimental Treatment1 Intervention
The IV Mg will start at 1 g/hour (25 ml/hour) within one hour following induction of anesthesia and stabilization of the patient. The infusion will continue for 24 hours and serum Mg levels will be monitored every 4 hours (+/-1 hour) for 28 hours following initiation of the Mg. Dose adjustments to the Mg infusion will be made as necessary to reach target serum Mg levels (3-5 mg/dl).
Group II: Normal SalinePlacebo Group1 Intervention
Patients randomized to placebo will receive an equal volume of normal saline (0.9% NS) placebo which will be administered as a continuous infusion at 25 ml/hour. The infusion will continue for 24 hours.

Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Magnesium sulfate for:
  • Seizure prevention in pre-eclampsia
  • Asthma exacerbation treatment
  • Constipation treatment
🇪🇺
Approved in European Union as Magnesium sulphate for:
  • Pre-eclampsia and eclampsia treatment
  • Hypomagnesemia treatment
🇨🇦
Approved in Canada as Magnesium sulfate for:
  • Seizure prevention in pre-eclampsia
  • Asthma exacerbation treatment

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Findings from Research

Magnesium sulfate (MgSO4) treatment in obstetrics has been associated with negative effects on the fetus and newborn, raising concerns about its safety in these populations.
There are conflicting reports regarding the tocolytic efficacy of magnesium sulfate, meaning its effectiveness in stopping preterm labor is still debated among researchers.
[Efficiency and safety of magnesium sulfate treatment in obstetrics].Mikołajek, W., Chlubek, D.[2017]
Magnesium sulfate is widely used in obstetrics for preventing seizures in women with preeclampsia and for stopping preterm labor, but it carries a risk of accidental overdose that can harm both mothers and babies.
Despite its routine use, vigilance is essential to ensure safety, and following the recommendations in this article can help reduce the risk of overdose and improve error detection before serious harm occurs.
Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety.Simpson, KR., Knox, GE.[2019]
Magnesium sulfate (MgSO4) was highly effective in controlling seizures in 459 cases of eclampsia, with a very low recurrence rate of only 1.31%.
The treatment demonstrated a low incidence of toxicity, with no life-threatening side effects, and resulted in a maternal mortality rate of 3.70% and perinatal mortality of 9.15%, indicating a good prognosis for both mothers and their babies.
Efficacy and safety of magnesium sulphate (MgSO4) in the treatment of eclampsia.Alauddin, M., Sarkar, MK., Munshi, S., et al.[2012]

References

[Efficiency and safety of magnesium sulfate treatment in obstetrics]. [2017]
Obstetrical accidents involving intravenous magnesium sulfate: recommendations to promote patient safety. [2019]
Efficacy and safety of magnesium sulphate (MgSO4) in the treatment of eclampsia. [2012]
[Magnesium sulfate in the prophylaxis of eclampsia: a retrospective study]. [2012]
Emergency medicine: magnesium sulphate injections and their pharmaceutical quality concerns. [2022]
Antitumor effect of seaweeds. IV. Enhancement of antitumor activity by sulfation of a crude fucoidan fraction from Sargassum kjellmanianum. [2003]
Antiviral activity against dengue virus of diverse classes of algal sulfated polysaccharides. [2023]
Marine Sulfated Polysaccharides as Promising Antiviral Agents: A Comprehensive Report and Modeling Study Focusing on SARS CoV-2. [2021]
The non-specific antiviral activity of polysulfates to fight SARS-CoV-2, its mutants and viruses with cationic spikes. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Antiviral effects of sulfated exopolysaccharide from the marine microalga Gyrodinium impudicum strain KG03. [2018]
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