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Osmotic Diuretic
Mannitol for Hemodialysis Complications
Phase 2 & 3
Recruiting
Led By Finnian R Mc Causland, MBBCH, MMSc
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Summary
This trial will compare the effects of mannitol (a sugar alcohol) to placebo on blood pressure and symptoms in adult dialysis patients.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Mannitol may cause side effects like fluid overload, electrolyte imbalances (like low sodium), headache, nausea, vomiting, and dizziness. However, these vary from person to person.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Intra-dialytic hypotension
Patient Symptoms
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mannitol
2019
Completed Phase 4
~2900
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,594 Total Patients Enrolled
Finnian R Mc Causland, MBBCH, MMScPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I undergo hemodialysis three times a week.I have not had a heart attack or stroke in the last month.My blood pressure often drops below 100 mmHg during dialysis.I have been on hemodialysis for more than 90 days.I am allergic to mannitol.My doctor expects I have less than 2 months to live.I am scheduled for a kidney transplant within the next 2 months.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Mannitol
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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