NCT04428372

MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 pressure stability.

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 intra-dialytic hypotension The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.

Conditions

• Hemodialysis Complication
• Hemodynamic Instability

Interventions

Type	Name	Description
DRUG	Mannitol	Hypertonic mannitol infusion
DRUG	0.9% saline	Normal saline 'placebo' arm

Timeline

• Start date: 2021-04-06
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2020-06-11
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study