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

Hemodynamic Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04428372
• Other study ID #: 2019P003681
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 6, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: Finnian R Mc Causland, MBBCh, MMSc
• Phone: 617-732-6432
• Email: fmccausland[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hemodynamic Instability

Intervention

Drug:
• Mannitol
Hypertonic mannitol infusion
• 0.9% saline
Normal saline 'placebo' arm

Locations

Country	Name	City	State
United States	Brigham and Women's	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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