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

Phase 2

Recruiting

• Conditions: Hemodialysis Complication; Hemodynamic Instability
• Interventions: Drug: 0.9% saline; Drug: Mannitol

• Registration Number: NCT04428372
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2021-04-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient Symptoms	4 weeks	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)

Secondary Outcome Measures

Name	Time	Method
Patient Symptoms	4 weeks	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)
Intra-dialytic hypotension	4 weeks	Comparison of change in average intra-dialytic systolic blood pressure change during mannitol arm, compared with during the placebo arm

Trial Locations

Locations (1)

Brigham and Women's; 🇺🇸 Boston, Massachusetts, United States