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Intravenous Magnesium in Patients Receiving Cisplatin

Published: August 7, 2020

Primary Outcome Measures

  1. Feasibility and acceptability as measured by participant rates of enrollment [ Time Frame: 6 months ]
    Feasibility assessed by % of patients that agree to participate. Project feasible if >30% of the patients approached agree to participate
  2. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0 [ Time Frame: Time of magnesium infusion till 2 days. ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secondary Outcome Measures

  1. Magnesium Level [ Time Frame: Day of surgery through postoperative day 3. ]
    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.
  2. Tubular Injury Markers [ Time Frame: From admission through postoperative day 3 ]
    Changes in urinary KIM-1 and urinary NGAL levels in order to assess intra- and interassay variability

Inclusion Criteria

  • Adults ≥18 years with malignant mesothelioma admitted for HIOCC. Because no dosing or adverse event data are currently available on the use of intravenous magnesium participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric studies.
  • Glomerular filtration rate (GFR)≥ 30 ml/min/1.73m2 at the time of enrollment
  • Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

  • Patients with a pre-treatment serum Magnesium level >3 mg/dl at the preoperative visit
  • Patients with AKI at the time of enrollment, assessed by Kidney Disease Improving Outcomes Criteria (serum creatinine increase ≥1.5x baseline)
  • Patients with estimated glomerular filtration rate <30 ml/min/1.73m2 at the time of enrollment
  • Patients with neuromuscular disease (e.g., amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myasthenia gravis, myositis)
  • Patients with sustained bradycardia (heart rate <50 beats per minute on 1 or more EKGs in the preceding 90 days) or 2nd degree AV heart block type 2 or higher with the absence of a functioning pacemaker
  • Participants who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to intravenous magnesium
  • Participants with uncontrolled intercurrent illness.
  • Participants with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because they may need magnesium for treatment of preeclampsia or eclampsia, apart from this study.
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