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

Mass General Brigham

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hemodialysis Complication

Hemodynamic Instability

Treatments

Drug: Mannitol

Drug: 0.9% saline

Study type

Interventional

Funder types

Other

Identifiers

NCT04428372

2019P003681

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

31 participants in 2 patient groups, including a placebo group

Mannitol

Experimental group

Description:

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

Treatment:

Drug: Mannitol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: 0.9% saline