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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis Complication; Hemodynamic Instability
• Intervention / Treatment: Drug: Mannitol; Drug: 0.9% saline

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Finnian R Mc Causland, MBBCh, MMSc; Phone Number: 617-732-6432; Email: fmccausland@bwh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's
      • Contact: Finnian Mc Causland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Symptoms	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)	4 weeks
Patient Symptoms	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)	4 weeks
Intra-dialytic hypotension	Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm	4 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Finnian R Mc Causland, MBBCH, MMSc, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Estimated): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: hemodialysis
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Natriuretic Agents; Diuretics, Osmotic; Diuretics; Mannitol
• Other Study ID Numbers: 2019P003681

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Modest sized single-center study with no plan to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No