This research study, is trying to determine the highest dose of magnesium that can be given safely to people with malignant mesothelioma receiving intraoperative chemotherapy with cisplatin who are at risk for acute kidney injury. The name(s) of the study drug involved in this study is * magnesium sulfate.
This research study is a phase 1 pilot study, which is the first time investigators are examining larger doses of magnesium in patients receiving cisplatin and the effect of intravenous magnesium administration on blood magnesium levels. In previous studies it was found that patients with lower blood magnesium levels were at higher risk of acute kidney injury. The study is looking to determine the best dose(s) of intravenous magnesium to administer safely without severe or unmanageable side effects in participants. The purpose of the study is also to determine the dose of intravenous magnesium needed to achieve a target level. The U.S. Food and Drug Administration (FDA) has not approved magnesium for people with mesothelioma receiving cisplatin but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment at participant's preoperative visit with their thoracic surgeon. Intravenous magnesium will be administered in the hospital, the night prior to surgery, and take place over 36 hours. Participants will followed for 4 days on postoperative days 1, 2, and 3. It is expected that about 10 people will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
5
Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Feasibility and acceptability as measured by participant rates of enrollment
Feasibility assessed by % of patients that agree to participate. Project feasible if \>30% of the patients approached agree to participate
Time frame: 6 months
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Time frame: Time of magnesium infusion till 2 days.
Magnesium Level
Assess the amount of IV magnesium needed to reach a target level of 3 to 4.8mg/dl. Magnesium levels will be measured at multiple time points. We want \>80% (≥32/40) of the time-averaged, postoperative magnesium levels to be within the target range of 3 to 4.8 mg/dl.
Time frame: Day of surgery through postoperative day 3.
Tubular Injury Markers
Changes in urinary KIM-1 and urinary NGAL levels in order to assess intra- and interassay variability
Time frame: From admission through postoperative day 3
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