NCT05730816RecruitingPhase 2
MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI
MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI
Source: ClinicalTrials.gov · Last updated 21 Nov 2025
Brief summary (registry, in English)
In this research study, investigators will test whether prophylactic high-dose IV Mg administration attenuates the risk of AKI in patients with malignant mesothelioma receiving intraoperative chemotherapy (HIOC) with cisplatin compared to placebo .
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- First submitted
- 7 Feb 2023
- Start date
- 4 Apr 2023
- Primary completion date
- 3 Apr 2027
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Mesothelioma
- NCT number
- NCT05730816
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 130
- From 4 Apr 2023 to the primary completion date, 3 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Positive COVID test in the 10 days prior to surgery
- Concurrent participation in a study with an alternative experimental therapy that may interact with IV Mg
Other illness
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis)
- Sinus bradycardia, defined as a heart rate (HR) \<55 beats per minute (bpm) detected on any ECG in the preceding 6 months
- Hypersensitivity to Mg sulfate
- Any condition that, in the view of the PI, might place the patient at increased risk or compromise the integrity of the study
Lab values
- eGFR\<45 ml/min/1.73m2 on either screening labs or preoperative labs, or end-stage kidney disease receiving renal replacement therapy. Screening labs refer to those obtained at the preoperative visit with the surgeon or within 90 days prior, whereas preoperative labs are obtained on the day of admission (typically one to three days priors to surgery).
- Serum Mg \>3 mg/dl on either screening labs or preoperative labs
Other
- Pregnant/breastfeeding
- High grade AV block (2nd degree AV block type II or 3rd degree AV block) without a pacemaker
- Prisoner
- Conflict with other study
Who the study is looking for
- 1\. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.