Using mannitol to improve blood pressure stability in hemodialysis patients
MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)
This study is testing if a sugar called mannitol can help people on dialysis have better blood pressure and feel more stable during their treatment.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT04428372 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of hypertonic mannitol compared to a placebo in adult patients undergoing maintenance hemodialysis who are prone to intra-dialytic hypotension. The study employs a randomized crossover design over a 4-week period to assess changes in patient symptoms and blood pressure stability during dialysis sessions. Participants will receive either mannitol or a saline placebo, with the primary goal of determining whether mannitol can reduce adverse symptoms and improve blood pressure outcomes. The trial aims to provide insights into better management strategies for patients experiencing hemodynamic instability during dialysis.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who have been on maintenance hemodialysis for more than 90 days and experience intra-dialytic hypotension.
Not a fit: Patients with recent acute myocardial infarction or stroke, severe hyperkalemia, or those with a life expectancy of less than two months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved blood pressure management and reduced symptoms for patients undergoing hemodialysis.
How similar studies have performed: Other studies have explored interventions for intra-dialytic hypotension, but the use of hypertonic mannitol in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Brigham and Women's — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Finnian R Mc Causland, MBBCH, MMSc — Brigham and Women's Hospital
- Study coordinator: Finnian R Mc Causland, MBBCh, MMSc
- Email: fmccausland@bwh.harvard.edu
- Phone: 617-732-6432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.