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

Last updated: February 13, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Active - Recruiting

Phase

2/3

Condition

Low Blood Pressure (Hypotension)

Treatment

0.9% saline

Mannitol

Clinical Study ID

NCT04428372
2019P003681
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theprior 4 weeks)
  • Hematocrit>21%
  • Written informed consent

Exclusion

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

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: 0.9% saline
Phase: 2/3
Study Start date:
April 06, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Brigham and Women's

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

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