Using magnesium to prevent kidney injury in mesothelioma patients during surgery
MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI
This study is testing if giving high doses of magnesium during surgery can help prevent kidney injury in patients with mesothelioma who are receiving chemotherapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05730816 on ClinicalTrials.gov |
What this trial studies
This phase 2, open-label randomized, placebo-controlled trial aims to determine if high-dose intravenous magnesium can reduce the risk of acute kidney injury (AKI) in patients with malignant mesothelioma undergoing intraoperative chemotherapy with cisplatin. A total of 130 patients will be randomly assigned to receive either magnesium sulfate or a placebo (normal saline) during surgery. Blood and urine samples will be collected before and after the procedure to explore additional outcomes related to kidney function. The magnesium infusion will be administered continuously for 24 hours, starting soon after anesthesia induction.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older with malignant mesothelioma scheduled for surgery involving intraoperative chemotherapy.
Not a fit: Patients with severe kidney impairment, certain neuromuscular diseases, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of kidney injury in patients undergoing chemotherapy for mesothelioma.
How similar studies have performed: While the use of magnesium for kidney protection is being explored, this specific approach in the context of mesothelioma and intraoperative chemotherapy is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon Exclusion Criteria: 1. eGFR\<45 ml/min/1.73m2 on either screening labs or preoperative labs, or end-stage kidney disease receiving renal replacement therapy. Screening labs refer to those obtained at the preoperative visit with the surgeon or within 90 days prior, whereas preoperative labs are obtained on the day of admission (typically one to three days priors to surgery). 2. Serum Mg \>3 mg/dl on either screening labs or preoperative labs 3. Pregnant/breastfeeding 4. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis) 5. Coronary artery disease, defined as any of the following in the prior year: a positive stress test; coronary angiogram indicating 1 or more vessels with \>70% stenosis; percutaneous coronary intervention with stents; or coronary artery bypass graft surgery 6. Sinus bradycardia, defined as a heart rate (HR) \<55 beats per minute (bpm) detected on any ECG in the preceding 6 months 7. High grade AV block (2nd degree AV block type II or 3rd degree AV block) without a pacemaker 8. Positive COVID test in the 10 days prior to surgery 9. Prisoner 10. Hypersensitivity to Mg sulfate 11. Concurrent participation in a study with an alternative experimental therapy that may interact with IV Mg 12. Any condition that, in the view of the PI, might place the patient at increased risk or compromise the integrity of the study 13. Conflict with other study
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Shruti Gupta, MD, MPH — Brigham and Women's Hospital
- Study coordinator: Shruti Gupta, MD, MPH
- Email: Sgupta21@bwh.harvard.edu
- Phone: 617-732-6383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.