MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
Purpose
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.
Conditions
- Hemodialysis Complication
- Hemodynamic Instability
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Mannitol |
intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis |
|
|
Placebo Comparator Placebo |
0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis |
|
Recruiting Locations
Brigham and Women's
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Contact:
Finnian Mc Causland
Finnian Mc Causland
More Details
- Status
- Recruiting
- Sponsor
- Brigham and Women's Hospital
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.