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Trial Title:
MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI
NCT ID:
NCT05730816
Condition:
Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Magnesium Sulfate
Conditions: Keywords:
Mesothelioma
Magnesium Sulfate
intraoperative cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Magnesium sulfate
Description:
Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with
cisplatin.
Arm group label:
Magnesium Sulfate
Intervention type:
Drug
Intervention name:
Normal Saline
Description:
Intravenous infusion of normal saline.
Arm group label:
Normal Saline
Summary:
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
.
Detailed description:
In this phase 2, open-label randomized, placebo-controlled trial, investigators will test
whether prophylactic high-dose IV Mg administration attenuates the risk of
HIOC-associated AKI in patients with malignant mesothelioma undergoing surgery with
HIOCC. Investigators will randomly assign 130 patients to receive IV Mg versus an equal
volume of normal saline (0.9% NS) placebo, of whom it is anticipated 80 will complete the
study. Investigators will also collect blood and urine pre- and postoperatively for
exploration of secondary outcomes.
Investigators will screen for eligibility at participant's preoperative visit with their
thoracic surgeon. Intravenous magnesium will be administered as a continuous infusion,
soon after induction and stabilization by anesthesia in the operating room. The magnesium
drip will start at 1 g/hour and will be titrated to achieve target levels of 3-5 mg/dl.
The total duration of the infusion will be 24 hours.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with
HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon
Exclusion Criteria:
1. 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).
2. Serum Mg >3 mg/dl on either screening labs or preoperative labs
3. Pregnant/breastfeeding
4. Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis,
multiple sclerosis, muscular dystrophy, myositis)
5. 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
6. Sinus bradycardia, defined as a heart rate (HR) <55 beats per minute (bpm) detected
on any ECG in the preceding 6 months
7. High grade AV block (2nd degree AV block type II or 3rd degree AV block) without a
pacemaker
8. Positive COVID test in the 10 days prior to surgery
9. Prisoner
10. Hypersensitivity to Mg sulfate
11. Concurrent participation in a study with an alternative experimental therapy that
may interact with IV Mg
12. Any condition that, in the view of the PI, might place the patient at increased risk
or compromise the integrity of the study
13. Conflict with other study
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02130
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shruti Gupta
Email:
sgupta21@bwh.harvard.edu
Contact backup:
Last name:
David E. Leaf
Email:
deleaf@bwh.harvard.edu
Start date:
April 4, 2023
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Agency class:
NIH
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05730816
