← Back to Search

Electrolyte Supplement

Magnesium Sulfate for Mesothelioma (MAGIC-AKI Trial)

Phase 2

Recruiting

Led By Shruti Gupta, MD, MPH

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

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

Concurrent participation in a study with an alternative experimental therapy that may interact with IV Mg

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Summary

This trial will study if giving high doses of magnesium before surgery can reduce the risk of kidney damage in people with mesothelioma getting chemotherapy.

Who is the study for?

This trial is for adults with malignant mesothelioma who are undergoing surgery with HIOC. Participants must be treated by Dr. Raphael Bueno or another BWH thoracic surgeon and have normal kidney function. It's not for those with slow heart rates, recent COVID, severe heart block without a pacemaker, pregnant/breastfeeding women, certain neuromuscular diseases, prisoners, magnesium allergy or high serum magnesium levels.

What is being tested?

The study is testing if giving high-dose IV Magnesium can reduce the risk of AKI in patients getting intraoperative chemotherapy with cisplatin for mesothelioma compared to a placebo (Normal Saline).

What are the potential side effects?

Possible side effects from Magnesium sulfate may include flushing, sweating, lowered blood pressure, confusion, muscle weakness and abnormal heart rhythms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult with mesothelioma planning surgery with HIOC at BWH.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had significant heart artery blockage or surgery for it in the last year.

Select...

I am not in a study that could affect my IV magnesium treatment.

Select...

My kidney function is very low or I am on dialysis.

Select...

I have a neuromuscular condition like myasthenia gravis or ALS.

Select...

I have a severe heart block without a pacemaker.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

AUC of SCr measured daily over 7 days in Mg- versus placebo-treated patients

Composite Global Rank

Secondary study objectives

AUC for platinum concentrations

Composite outcome of RRT/in-hospital death

Incident AKI

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Magnesium SulfateExperimental Treatment1 Intervention

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).

Group II: Normal SalinePlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnesium sulfate

2018

Completed Phase 4

~1610

0 / 6Eligibility criteria met