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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Hemodialysis Complication Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mannitol

intravenous 20% mannitol, 0.25g/kg/hour (maximum 25g/hour; maximum 75g per session; maximum volume 375mL/session) as a continuous infusion during dialysis

Group Type EXPERIMENTAL

Mannitol

Intervention Type DRUG

Hypertonic mannitol infusion

Placebo

0.9% saline at a rate of 1.25mL/kg/hour (maximum volume 375mL) as a continuous infusion during dialysis

Group Type PLACEBO_COMPARATOR

0.9% saline

Intervention Type DRUG

Normal saline 'placebo' arm

Interventions

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Mannitol

Hypertonic mannitol infusion

Intervention Type DRUG

0.9% saline

Normal saline 'placebo' arm

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No