Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

• Status: Completed
• Trial end date: 2021-06-22
• Target enrollment: 0
• Participant gender: All

Summary

Individuals with kidney failure receiving maintenance hemodialysis (HD) have high mortality rates, driven largely by cardiovascular causes. Volume-related factors are critical, modifiable contributors to cardiovascular complications. Reversing volume overload has been shown to improve blood pressure and cardiac remodeling. Use of loop diuretics may represent a pragmatic, low-cost, and low-burden strategy to improve outcomes in people receiving HD. Lack of data on optimal furosemide dosing, safety, and acceptability are barriers to expanded use. This study investigates whether oral furosemide is safe and effective at increasing urine volume in HD patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Diuretics; Furosemide; Sodium Potassium Chloride Symporter Inhibitors

Criteria

Inclusion Criteria:

• Patient self-report of at least 1 cup urine/24-hours

• Age ≥18 years

• Receipt of thrice weekly in-center HD at a participating clinic (UNC-associated Carolina Dialysis- Carrboro, Siler City, Pittsboro, Sanford, and Lee County)

• ≥60 days receiving in-center HD

• Willingness to take study medication and undergo study testing

• Ability to provide informed consent

Exclusion Criteria:

• Known allergy to loop diuretic

• History of poor adherence to HD or medical regimen per nephrologist

• >1 hospitalization in prior 30-days

• Frequent hypotension (systolic BP <80 mmHg at >30% of HD treatments in prior 30-days)

• Cirrhosis per nephrologist

• Hearing disorder per nephrologist

• Serum potassium <3.5 mEq/L, magnesium <1 mg/dL, or corrected calcium <8 mg/dL in prior 30-days

• Taking a non-loop diuretic (e.g. spironolactone, eplerenone, ethacrynic acid, thiazides)

• Taking an aminoglycoside, cisplatin, methotrexate, cyclosporine, adrenocorticotropic hormone (ACTH), lithium, phenytoin, or oral/intravenous steroid

• Natural licorice consumption

• Prisoners, patients with significant mental illness

• Pregnant patients and nursing mothers