Mannitol for Hemodialysis Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether mannitol, administered during dialysis, can manage symptoms and stabilize blood pressure in individuals who frequently experience low blood pressure during their sessions. Participants will receive either mannitol (also known as Osmitrol or Resectisol) or a placebo (a harmless saltwater solution) to determine any noticeable differences. It suits those who have undergone dialysis for over 90 days and often experience low blood pressure during treatment. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mannitol has been used for many years without links to major birth defects or miscarriages, indicating a certain level of safety. However, mannitol can cause serious side effects. Excessive intake has led to issues such as changes in blood volume, kidney problems, or even seizures. Heart problems, including low blood pressure and a fast heartbeat, have also been reported. In some cases, kidney issues can become severe, especially for those with pre-existing kidney problems. These risks often relate to excessive intake or existing health conditions. Overall, mannitol is generally well-tolerated, but awareness of these possible side effects is important.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for hemodialysis complications, which often include medications to manage fluid overload and electrolyte imbalances, mannitol offers a unique approach. Mannitol is administered as a continuous intravenous infusion during dialysis sessions, using a 20% solution. Researchers are excited about mannitol because it acts as an osmotic diuretic, helping to prevent complications by drawing excess fluid out of the blood and into the urine more effectively. This mechanism could potentially reduce common dialysis-related issues like low blood pressure and cramping, making treatment sessions more comfortable for patients.
What evidence suggests that mannitol might be an effective treatment for hemodialysis complications?
Research has shown that mannitol, which participants in this trial may receive, might help maintain steady blood pressure during hemodialysis. One study found that mannitol reduced issues like headaches and restlessness in patients new to this treatment. Some evidence suggests that mannitol may protect kidney function in certain cases, potentially benefiting individuals with long-term kidney disease. However, results are mixed, as some studies have linked mannitol to worse outcomes in other conditions. Mannitol's ability to draw fluid into the blood vessels might help prevent blood pressure from dropping during dialysis.678910
Who Is on the Research Team?
Finnian R Mc Causland, MBBCH, MMSc
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for adults over 18 who are on maintenance hemodialysis for at least 90 days and often have low blood pressure during treatment. They must not be pregnant, planning a kidney transplant soon, or have had a recent heart attack or stroke. Also, they can't join if they're allergic to mannitol or have very high potassium levels.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either hypertonic mannitol or placebo during dialysis sessions to assess effects on blood pressure stability and symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mannitol
Mannitol is already approved in United States, European Union, Canada for the following indications:
- Reduction of intracranial pressure
- Promotion of diuresis
- Reduction of intraocular pressure
- Reduction of intracranial pressure
- Treatment of cerebral edema
- Reduction of intracranial pressure
- Promotion of diuresis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor