Using magnesium to prevent kidney injury in mesothelioma patients during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.