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

• Status: Recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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