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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
31
Hypertonic mannitol infusion
Normal saline 'placebo' arm
Brigham and Women's
Boston, Massachusetts, United States
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)
Time frame: 4 weeks
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)
Time frame: 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)
Time frame: 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
Time frame: 4 weeks
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