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

ArmDescriptionAssigned 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
  • Drug: Mannitol
    Hypertonic mannitol infusion
Placebo Comparator
Placebo 		0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis
  • Drug: 0.9% saline
    Normal saline 'placebo' arm

Recruiting Locations

Brigham and Women's
Boston, Massachusetts 02115
Contact:
Finnian Mc Causland

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Finnian R Mc Causland, MBBCh, MMSc
617-732-6432
fmccausland@bwh.harvard.edu

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.