Mannitol for Hemodialysis Complications

Overseen By Finnian R Mc Causland, MBBCh, MMSc

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Brigham and Women's Hospital

Disqualifiers: Recent MI or stroke, Pregnancy, Institutionalized, Life expectancy <2 months, Planned transplant, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

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.

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypertonic mannitol or placebo during dialysis sessions to assess effects on blood pressure stability and symptoms

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mannitol

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+