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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mannitol | Experimental | intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis |
|
| Placebo | Placebo Comparator | 0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mannitol | Drug | Hypertonic mannitol infusion |
| |
| 0.9% saline |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Finnian R Mc Causland, MBBCH, MMSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's | Boston | Massachusetts | 02115 | United States |
Modest sized single-center study with no plan to share individual participant data
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| ID | Term |
|---|---|
| D008353 | Mannitol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Drug |
Normal saline 'placebo' arm |
|
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 |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |