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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
MAGIC-AKI Trial 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.Check my eligibility
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).See study design
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.
MAGIC-AKI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with mesothelioma planning surgery with HIOC at BWH.
MAGIC-AKI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AUC of SCr measured daily over 7 days in Mg- versus placebo-treated patients
Composite Global Rank
Secondary outcome measures
AUC for platinum concentrations
Composite outcome of RRT/in-hospital death
Incident AKI
+6 moreSide effects data
From 2012 Phase 4 trial • 200 Patients • NCT0134251030%
Pain with injection of propofol
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium
MAGIC-AKI 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
~1630
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,612 Previous Clinical Trials
11,470,445 Total Patients Enrolled
6 Trials studying Mesothelioma
477 Patients Enrolled for Mesothelioma
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
6,952,684 Total Patients Enrolled
1 Trials studying Mesothelioma
65 Patients Enrolled for Mesothelioma
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,315,111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not in a study that could affect my IV magnesium treatment.I have had significant heart artery blockage or surgery for it in the last year.You are allergic to magnesium sulfate.My kidney function is very low or I am on dialysis.I am an adult with mesothelioma planning surgery with HIOC at BWH.I have a neuromuscular condition like myasthenia gravis or ALS.Your heart rate has been consistently lower than 55 beats per minute in the past 6 months.I tested positive for COVID-19 within 10 days before my surgery.I have a severe heart block without a pacemaker.Your blood test shows that your magnesium levels are higher than 3 mg/dl.
Research Study Groups:
This trial has the following groups:- Group 1: Magnesium Sulfate
- Group 2: Normal Saline
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA ratified Magnesium Sulfate as a viable medical treatment?
"Our team at Power rated Magnesium Sulfate's safety level 2 on the 1 to 3 scale, because although there are some reports of its security, it is still in Phase 2 trials and has yet to be proven effective."
Answered by AI
Are there any open slots available for participants in this research?
"As attested to on clinicaltrials.gov, this medical trial is still open for registration and recruitment of participants. The initial posting date was April 4th 2023 and the page was last revised on April 3rd 2023."
Answered by AI
What objectives does this research endeavor seek to accomplish?
"This 7-day trial will primarily assess Composite Global Rank. Secondary goals include measuring Maximum AKI stage (KDIGO staging), Proportion of patients with serum Mg levels in the 3-5 mg/dl range during treatment hours (+8 to +24 relative to infusion start) and AUC for platinum concentrations collected at various time points."
Answered by AI
How many participants are currently partaking in this experiment?
"Affirmative. Clinicaltrials.gov's records show that, after being posted on April 4th 2023 and last updated in the 3rd of April, this medical research is actively searching for participants - with a goal of 130 patients from 1 location."
Answered by AI
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