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Completed

NCT Number: NCT04428372

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

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.

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Key information

Conditions

Hemodialysis Complication Hemodynamic Instability

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brigham and Women's

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

Hypertonic mannitol infusion

0.9% saline

Drug

Normal saline 'placebo' arm

Primary outcomes

  1. Patient Symptoms

    Time frame: 4 weeks

    Comparison of average patient symptom score during mannitol arm using dialysis symptom index compared with the average score during the placebo arm (scale 0-150; higher scores worse)

Secondary outcomes

  1. Patient Symptoms

    Time frame: 4 weeks

    Comparison of average patient symptom score during mannitol arm using modified Edmonton symptom assessment system compared with the average score during the placebo arm (scale 0-100; higher scores worse)

  2. Patient Symptoms

    Time frame: 4 weeks

    Comparison of average patient symptom score during mannitol arm using SMAART HD questionnaire compared with the average score during the placebo arm (scale 0-60 on 12-questions, higher scores worse)

  3. Intra-dialytic hypotension

    Time frame: 4 weeks

    Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 11, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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