30 Participants Needed

Mannitol for Hemodialysis Complications

FR
Overseen ByFinnian R Mc Causland, MBBCh, MMSc
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.

Research Team

FR

Finnian R Mc Causland, MBBCH, MMSc

Principal Investigator

Brigham and Women's Hospital

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
See 2 more

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.
See 5 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MannitolExperimental Treatment1 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: PlaceboPlacebo Group1 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:

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Approved in United States as Osmitrol for:
  • Reduction of intracranial pressure
  • Promotion of diuresis
  • Reduction of intraocular pressure
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Approved in European Union as Mannitol for:
  • Reduction of intracranial pressure
  • Treatment of cerebral edema
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Approved in Canada as Mannitol for:
  • 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

Trials
1,694
Recruited
14,790,000+
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