Intravenous Magnesium in Patients Receiving Cisplatin
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Mesothelioma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This research study is a phase 1 pilot study, which is the first time investigators are examining larger doses of magnesium in patients receiving cisplatin and the effect of intravenous magnesium administration on blood magnesium levels. In previous studies it was found that patients with lower bloo...
This research study is a phase 1 pilot study, which is the first time investigators are examining larger doses of magnesium in patients receiving cisplatin and the effect of intravenous magnesium administration on blood magnesium levels. In previous studies it was found that patients with lower blood magnesium levels were at higher risk of acute kidney injury. The study is looking to determine the best dose(s) of intravenous magnesium to administer safely without severe or unmanageable side effects in participants. The purpose of the study is also to determine the dose of intravenous magnesium needed to achieve a target level. The U.S. Food and Drug Administration (FDA) has not approved magnesium for people with mesothelioma receiving cisplatin but it has been approved for other uses. The research study procedures include: screening for eligibility and study treatment at participant's preoperative visit with their thoracic surgeon. Intravenous magnesium will be administered in the hospital, the night prior to surgery, and take place over 36 hours. Participants will followed for 4 days on postoperative days 1, 2, and 3. It is expected that about 10 people will take part in this research study.
Tracking Information
- NCT #
- NCT04481672
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Shruti Gupta, MD, MPH Brigham and Women's Hospital Principal Investigator: David E. Leaf, MD, MMSc Brigham and Women's Hospital