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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05730816
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Mesothelioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Magnesium sulfate — DRUG
    Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.
  • Normal Saline — DRUG
    Intravenous infusion of normal saline.

Study Details

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 .

Key Dates

Start date
Apr 4, 2023
Status verified
Nov 2025
Primary completion
Apr 3, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Magnesium Sulfate
    The IV Mg will start at 1 g/hour (25 ml/hour) within one hour following induction of anesthesia and stabilization of the patient. The infusion will continue for 24 hours and serum Mg levels will be monitored every 4 hours (+/-1 hour) for 28 hours following initiation of the Mg. Dose adjustments to the Mg infusion will be made as necessary to reach target serum Mg levels (3-5 mg/dl).
  • Placebo Comparator: Normal Saline
    Patients randomized to placebo will receive an equal volume of normal saline (0.9% NS) placebo which will be administered as a continuous infusion at 25 ml/hour. The infusion will continue for 24 hours.

Primary Outcome Measure

AUC of SCr measured daily over 7 days in Mg- versus placebo-treated patients [ Time Frame: 7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02130
Shruti Gupta
[email protected]
David E. Leaf
[email protected]

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

Related Studies