# Pilot feasibility study of loop diuretics among individuals receiving hemodialysis

> **NIH NIH R03** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $116,625

## Abstract

PROJECT SUMMARY/ABSTRACT
Individuals receiving maintenance hemodialysis (HD) have exceedingly high mortality, driven largely by
cardiovascular causes. Volume-related factors including volume overload, large interdialytic weight gains
(IDWGs), and higher ultrafiltration (UF) rates are critical, modifiable contributors to cardiovascular
complications such as hypertension, arterial stiffness, left ventricular hypertrophy, and heart failure. Reversing
volume overload has been shown to improve blood pressure and cardiac remodeling. Lower IDWGs and UF
rates are associated with lower rates of intradialytic hypotension and less myocardial ischemia on cardiac
imaging. Oral loop diuretics are one potential strategy to increase urine output and reduce volume-associated
complications in HD patients. Observational data show associations between loop diuretic use and lower
IDWG, less intradialytic hypotension and fewer hospitalizations. Diuretics may represent a pragmatic, low-cost
strategy to improve outcomes in HD patients. However, lack of data on optimal dosing, safety, and
acceptability are barriers to expanded use. To fill this knowledge gap and generate preliminary data necessary
for a subsequent clinical trial, we propose an 18-week open label, pilot feasibility study to test if escalating
doses of furosemide are safe, well tolerated, and effective at increasing urine volume in HD patients. In an
initial 6-week dose-titration period (Aim 1), we will evaluate the short-term safety and efficacy of escalating oral
furosemide doses in 36 HD patients with residual urine output. In a subsequent 12-week follow-up period (Aim
2), we will evaluate the longer-term patient acceptance of and adherence to furosemide, and the longer-term
safety and efficacy of furosemide. The valuable data generated from this pilot study will: 1) identify potential
barriers to recruitment, 2) inform optimal furosemide dose selection and titration, and 3) provide key safety
data, all essential factors in determining the merit of a larger trial. Pilot data will also inform power calculations
necessary to design an R01-level clinical trial that will test if furosemide reduces volume-related complications
in HD patients.

## Key facts

- **NIH application ID:** 9953040
- **Project number:** 1R03DK124651-01
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Jennifer E Flythe
- **Activity code:** R03 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $116,625
- **Award type:** 1
- **Project period:** 2020-02-20 → 2022-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9953040

## Citation

> US National Institutes of Health, RePORTER application 9953040, Pilot feasibility study of loop diuretics among individuals receiving hemodialysis (1R03DK124651-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9953040. Licensed CC0.

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