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

NCT04428372 | Completed Phase 2 FDA Drug

• 1 other identifier: 2019P003681
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemodialysis Complication; Hemodynamic Instability

Keywords

hemodialysis

Outcome Measures

Primary Outcomes (1)

• Patient Symptoms

  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)

  4 weeks

Secondary Outcomes (3)

• Patient Symptoms

  4 weeks

• Patient Symptoms

  4 weeks

• Intra-dialytic hypotension

  4 weeks

Study Arms (2)

Mannitol

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis

Drug: 0.9% saline

Interventions

Mannitol DRUG

Hypertonic mannitol infusion

Mannitol

0.9% saline DRUG

Normal saline 'placebo' arm

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Mannitol; Saline Solution

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Finnian R Mc Causland, MBBCH, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Physician

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: April 6, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)