MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI (MAGIC-AKI)
Mesothelioma
About this trial
This is an interventional prevention trial for Mesothelioma focused on measuring Mesothelioma, Magnesium Sulfate, intraoperative cisplatin
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: 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). Serum Mg >3 mg/dl on either screening labs or preoperative labs Pregnant/breastfeeding Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis) 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 Sinus bradycardia, defined as a heart rate (HR) <55 beats per minute (bpm) detected on any ECG in the preceding 6 months High grade AV block (2nd degree AV block type II or 3rd degree AV block) without a pacemaker Positive COVID test in the 10 days prior to surgery Prisoner Hypersensitivity to Mg sulfate Concurrent participation in a study with an alternative experimental therapy that may interact with IV Mg Any condition that, in the view of the PI, might place the patient at increased risk or compromise the integrity of the study Conflict with other study
Sites / Locations
- Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Magnesium Sulfate
Normal Saline
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).
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.