Magnesium Sulfate for Mesothelioma
(MAGIC-AKI Trial)
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?
How does the drug Magnesium Sulfate differ from other treatments for mesothelioma?
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
David E. Leaf, MD, MMSc
Principal Investigator
Brigham and Women's Hospital
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either high-dose IV magnesium or placebo during surgery with HIOC
Immediate Postoperative Monitoring
Participants are monitored for serum magnesium levels and other secondary outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of AKI and other outcomes
Treatment Details
Interventions
- Magnesium Sulfate
Magnesium Sulfate is already approved in United States, European Union, Canada for the following indications:
- Seizure prevention in pre-eclampsia
- Asthma exacerbation treatment
- Constipation treatment
- Pre-eclampsia and eclampsia treatment
- Hypomagnesemia treatment
- 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
National Institutes of Health (NIH)
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator