Status:
COMPLETED
MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Hemodialysis Complication
Hemodynamic Instability
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 pr...
Detailed Description
A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants will be performed over a 4-week period to determine the effect on: * Patient symptoms * The magnitude of intr...
Eligibility Criteria
Inclusion
- Maintenance HD (\>90 days)
- Age ≥18y
- Thrice-weekly HD
- IDH-prone (defined as nadir intra-dialytic SBP \<100 mmHg in ≥30% of sessions in the prior 4 weeks)
- Hematocrit\>21%
- Written informed consent
Exclusion
- Acute myocardial infarction or stroke within one month
- Pre-HD serum potassium \>6.5 mmol/L in last 4 weeks
- Pregnancy
- Institutionalized individuals
- Life expectancy \<2 months
- Planned renal transplant within 2 months
- Active enrollment in another interventional trial
- Known allergy to mannitol
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04428372
Start Date
April 6 2021
End Date
December 31 2024
Last Update
November 24 2025
Active Locations (1)
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1
Brigham and Women's
Boston, Massachusetts, United States, 02115