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

Description

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 .

Conditions

Mesothelioma

Study Overview

Study Details

Study overview

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 .

MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI

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

Condition
Mesothelioma
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Shruti Gupta, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

David E. Leaf, MD, MMSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2028-01-01