Clinical trial · Interventional
Intravenous Magnesium in Patients Receiving Cisplatin
Pilot and Feasibility Study of Intravenous Magnesium in Patients Receiving Hyperthermic Intraoperative Chemotherapy With Cisplatin (HIOCC)
NCT04481672CI-TRIAL-00055908completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magnesium Sulfate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Magnesium Sulfate
- description
- Starting the night before surgery participants will receive intravenous infusion of magnesium over approximately 36 hours. Dosage amounts will vary among participants as the study is determining the highest dose of magnesium that can be administered safely without severe or unmanageable side effects. The first 5 participants of the study will all receive the same dose of magnesium. The decision to test other doses of magnesium in 5 additional participants will depend on magnesium levels and dose tolerance outcomes in the first 5 participants. Participants will be followed for 4 days and undergo blood test to measure magnesium levels at the time of hospital admittance, the morning prior to the surgery, twice immediately after surgery, and twice a day for 3 days after the surgery.
- interventionNames
- Drug: Magnesium Sulfate
Primary outcomes (2)
- measure
- Feasibility and acceptability as measured by participant rates of enrollment
- timeFrame
- 6 months
- description
- Feasibility assessed by % of patients that agree to participate. Project feasible if \>30% of the patients approached agree to participate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \>2.5 mg/dl or \<1.3 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.
References
Publications (0)
Data not yet available
No reference posted for this study.