Mannitol for Hemodialysis Complications

Recruiting in Palo Alto (17 mi)

Overseen by Finnian R Mc Causland, MBBCH, MMSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: Brigham and Women's Hospital

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This proposal will measure the effects of mannitol administration versus placebo in hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in patient symptoms and blood pressure stability.

Eligibility Criteria

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

I undergo hemodialysis three times a week.

Hematocrit>21%

Written informed consent

Exclusion Criteria

Institutionalized individuals

Pre-HD serum potassium >6.5 mmol/L in last 4 weeks

I have not had a heart attack or stroke in the last month.

Participant Groups

The study is testing whether mannitol can help maintain stable blood pressure in patients who experience significant drops during hemodialysis compared to the usual saline solution. Participants will receive either mannitol or saline while undergoing their regular dialysis treatments.

Group I: Mannitol Experimental Treatment 1 Intervention

intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis

Group II: Placebo Placebo Group 1 Intervention

0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis

Mannitol is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Osmitrol for:

• Reduction of intracranial pressure
• Promotion of diuresis
• Reduction of intraocular pressure

🇪🇺 Approved in European Union as Mannitol for:

• Reduction of intracranial pressure
• Treatment of cerebral edema

🇨🇦 Approved in Canada as Mannitol for:

• Reduction of intracranial pressure
• Promotion of diuresis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Brigham and Women's Boston, MA

Who Is Running the Clinical Trial?

Brigham and Women's Hospital Lead Sponsor

References