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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hemodialysis Complication, Hemodynamic Instability

Intervention / Treatment
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* Drug: Mannitol
* Drug: 0.9% saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mannitol<br>intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis | Drug: Mannitol<br>* Hypertonic mannitol infusion<br>|
| Placebo Comparator: Placebo<br>0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis | Drug: 0.9% saline<br>* Normal saline 'placebo' arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis