Hemodialysis Complication, Hemodynamic Instability
Conditions
Keywords
hemodialysis
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.
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.
Interventions
DRUGMannitol
Hypertonic mannitol infusion
DRUG0.9% saline
Normal saline 'placebo' arm
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Symptoms | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Symptoms | 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) |
| Intra-dialytic hypotension | 4 weeks | Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm |
Countries
United States
Outcome results
None listed