MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Feb 15, 2023

Keywords

ClinConnect Summary

The MAGIC AKI trial is a research study designed to see if giving high doses of magnesium through an IV can help prevent kidney problems in patients with malignant mesothelioma who are undergoing a specific type of chemotherapy during surgery. This trial is focused on patients who are 18 years or older and are scheduled to have surgery with a specialized doctor. To participate, patients should not have certain health issues, like severe kidney disease or heart problems, as these may increase risks during the study.

If you join this trial, you'll receive either the magnesium treatment or a placebo (a treatment that looks like the real thing but has no active ingredients) while you are undergoing chemotherapy. The goal is to determine whether magnesium can protect your kidneys during this process. The study is currently recruiting participants, and it's important to discuss with your doctor if you meet the eligibility criteria and if this trial is a good option for you.

Gender

ALL

Eligibility 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