MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI (MAGIC-AKI)
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ClinicalTrials.gov Identifier: NCT05730816 |
Recruitment Status :
Recruiting
First Posted : February 16, 2023
Last Update Posted : April 5, 2023
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Tracking Information | |||||||||||||||
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First Submitted Date ICMJE | February 7, 2023 | ||||||||||||||
First Posted Date ICMJE | February 16, 2023 | ||||||||||||||
Last Update Posted Date | April 5, 2023 | ||||||||||||||
Actual Study Start Date ICMJE | April 4, 2023 | ||||||||||||||
Estimated Primary Completion Date | April 3, 2027 (Final data collection date for primary outcome measure) | ||||||||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||
Descriptive Information | |||||||||||||||
Brief Title ICMJE | MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI | ||||||||||||||
Official Title ICMJE | MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI | ||||||||||||||
Brief 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 . |
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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. |
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Study Type ICMJE | Interventional | ||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Mesothelioma | ||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||
Recruitment Status ICMJE | Recruiting | ||||||||||||||
Estimated Enrollment ICMJE |
130 | ||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||
Estimated Study Completion Date ICMJE | January 1, 2028 | ||||||||||||||
Estimated Primary Completion Date | April 3, 2027 (Final data collection date for primary outcome measure) | ||||||||||||||
Eligibility Criteria ICMJE | 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:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||||||||
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Administrative Information | |||||||||||||||
NCT Number ICMJE | NCT05730816 | ||||||||||||||
Other Study ID Numbers ICMJE | 2023p000276 K23DK125672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Shruti Gupta, Brigham and Women's Hospital | ||||||||||||||
Original Responsible Party | Same as current | ||||||||||||||
Current Study Sponsor ICMJE | Brigham and Women's Hospital | ||||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Brigham and Women's Hospital | ||||||||||||||
Verification Date | April 2023 | ||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |