RECRUITING

MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI

Conditions

Mesothelioma Magnesium Sulfate intraoperative cisplatin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 .

Official Title

MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI

Quick Facts

Study Start:2023-04-04

Study Completion:2028-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05730816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon	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

Inclusion Criteria

Exclusion Criteria

1. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon

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

Contacts and Locations

Study Contact

Shruti Gupta, MD, MPH

CONTACT

617-732-6383

Sgupta21@bwh.harvard.edu

Principal Investigator

Shruti Gupta, MD, MPH

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

David E. Leaf, MD, MMSc

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02130

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Shruti Gupta, MD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
David E. Leaf, MD, MMSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-04

Study Completion Date2028-01-01

Study Record Updates

Study Start Date2023-04-04

Study Completion Date2028-01-01

Terms related to this study

Keywords Provided by Researchers

Mesothelioma
Magnesium Sulfate
intraoperative cisplatin

Additional Relevant MeSH Terms

Mesothelioma