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TerminatedNCT05915286DIURESEDUpdated May 8, 2026

Diuretic Use in Hemodialysis Patients With Residual Renal Function

A Phase 4 interventional study of Furosemide and Chlorthalidone in End Stage Renal Disease on Dialysis, sponsored by University of Alberta. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.

Sponsored by University of Alberta · Phase 4, Interventional, and Treatment

Why this study was terminated
Personnel/staffing issues.
Phase
Phase 4
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This pilot trial will evaluate the use of diuretic medications (furosemide and chlorthalidone) in participants on dialysis to see if these medications work to preserve existing kidney function, increase urine output, and reduce weight gain between dialysis treatments. Diuretics, which are sometimes called water pills, help the body to get rid of salt (sodium) and water. There are currently no guidelines for the use of diuretic medications in dialysis patients, including the type to use, or how much to use.

Read the detailed description

Fluid overload, or extracellular fluid volume expansion, in patients on hemodialysis is an important predictor of mortality. It is associated with hypertension and left ventricular hypertrophy - both risk factors for cardiovascular disease. In the United States, 80% of patients receiving hemodialysis have hypertension and 40% of patients on hemodialysis die from cardiovascular disease. The pathophysiology of hypertension in these patients is multifactorial, however, combined excess fluid and sodium is a key contributor.

While ultrafiltration (removal of fluid through dialysis) is important in managing fluid overload, fluid removed by hemodialysis is a non-physiological process which imposes hemodynamic stress on the cardiovascular system in uremic patients. This system is already maladaptive as a result of decreased baroreceptor sensitivity and increased vascular stiffness, leading to higher risk of hemodynamic instability when fluid is removed from the intravascular compartment. In patients who are anuric, restriction of fluid and sodium intake and ultrafiltration are the only options for volume control. In patients who continue to produce urine, however, optimizing the amount of urine produced could improve fluid overload and decrease cardiovascular stress.

Previous studies have shown that patients on hemodialysis who have residual renal function have better volume and sodium control. Higher residual renal function and higher urine output lead to a lower interdialytic weight gain in patients receiving hemodialysis; each of these factors have been associated with lower mortality. One intervention that may increase or help maintain residual renal function and increase urine output and therefore reduce interdialytic weight gain is diuretic therapy, which promotes the excretion of sodium and water by the native kidneys. Questions remain regarding the dose-response of the drug furosemide, about the utility of adding the drug chlorthalidone, and their clinical affects.

The main objective of this study is to determine the effects of starting, and escalating doses of diuretic medications (furosemide +/- chlorthalidone) on 24-hour urine output (volume) over a five-week period in patients on hemodialysis who produce >200cc per day of urine.

Secondary objectives are:

  1. To evaluate the effect of diuretic medications on residual renal function
  2. To evaluate the effect of different doses of diuretics on interdialytic weight gain, ultrafiltration rates and intradialytic hypotension
  3. To examine the effect of diuretics on patient reported outcomes
  4. To evaluate adverse effects of different doses of diuretics
  5. To measure serum furosemide levels in this patient population
02

Conditions studied

  • End Stage Renal Disease on Dialysis
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients (age 18 years or older), who are within their first 12 months of chronic (expected to need dialysis for at least 6 months), in-centre hemodialysis therapy, and
  • Residual renal function defined as 24-hour urine volume >200cc, and
  • Life expectancy of at least 6 months, and
  • Participants must be able to understand the consent process and be able to sign a consent form or have a substitute decision maker who is able to understand and sign consent on their behalf. In the case of non-English speaking participants, a translator service will be used to provide study information and obtain consent.

Exclusion criteria

Exclusion Criteria:

  • Unable to complete baseline urine collection
  • Documented allergy or adverse reaction to furosemide or chlorthalidone.
  • Unable to take oral medications
  • Patients expecting to change modality (peritoneal dialysis, home dialysis) or to receive a renal transplant in the next 6 weeks
  • History of hypokalemia (\<3.0 mmol/L), hypomagnesemia (\<0.6mmol/L), or hypocalcaemia (\<1.9mmol/L) in preceding 2 weeks.
  • Already participating in another study and one of the studies could interfere with the other study
  • Use of loop, or thiazide diuretic medications in the last week (if a patient is on chronic diuretics, they would need to be discontinued for 1 week before starting the trial)
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Diuretic Therapy

    Drug: Furosemide · Drug: Chlorthalidone

Interventions

  • DrugFurosemide

    Each participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily.

  • DrugChlorthalidone

    Each participant will have a 2 week period of no diuretic use followed by 3 weeks of escalating doses: 1) initially furosemide twice daily, then (2) an increased dose of furosemide twice daily, and in the final week, (3) the addition of chlorthalidone once daily.

06

What researchers measure

Primary outcomes

  1. Change in 24-hour urine output

    Change in urine output measured from 24-hour urine collection.

    Time frame: Week 1

  2. Change in 24-hour urine output

    Change in urine output measured from 24-hour urine collection.

    Time frame: Week 2

  3. Change in 24-hour urine output

    Change in urine output measured from 24-hour urine collection.

    Time frame: Week 3

  4. Change in 24-hour urine output

    Change in urine output measured from 24-hour urine collection.

    Time frame: Week 4

  5. Change in 24-hour urine output

    Change in urine output measured from 24-hour urine collection.

    Time frame: Week 5

  6. Change in residual renal function

    Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

    Time frame: Week 1

  7. Change in residual renal function

    Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

    Time frame: Week 2

  8. Change in residual renal function

    Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

    Time frame: Week 3

  9. Change in residual renal function

    Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

    Time frame: Week 4

  10. Change in residual renal function

    Calculated based on weekly bloodwork (urea and creatinine levels) and 24-hour urine collection.

    Time frame: Week 5

Secondary outcomes

  1. Interdialytic weight gain

    Patient weight measured in kilograms

    Time frame: Week 1

  2. Interdialytic weight gain

    Patient weight measured in kilograms

    Time frame: Week 2

  3. Interdialytic weight gain

    Patient weight measured in kilograms

    Time frame: Week 3

  4. Interdialytic weight gain

    Patient weight measured in kilograms

    Time frame: Week 4

  5. Interdialytic weight gain

    Patient weight measured in kilograms

    Time frame: Week 5

  6. Patient-reported outcomes - ESAS-r

    Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.

    Time frame: Week 1

  7. Patient-reported outcomes - ESAS-r

    Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.

    Time frame: Week 2

  8. Patient-reported outcomes - ESAS-r

    Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.

    Time frame: Week 3

  9. Patient-reported outcomes - ESAS-r

    Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.

    Time frame: Week 4

  10. Patient-reported outcomes - ESAS-r

    Patient reported outcomes using the Edmonton Symptom Assessment System-revised (ESAS-r) questionnaire.

    Time frame: Week 5

  11. Patient-reported outcomes - Muscle cramps

    Patient reported outcomes using a muscle cramps question.

    Time frame: Week 1

  12. Patient-reported outcomes - Muscle cramps

    Patient reported outcomes using a muscle cramps question.

    Time frame: Week 2

  13. Patient-reported outcomes - Muscle cramps

    Patient reported outcomes using a muscle cramps question.

    Time frame: Week 3

  14. Patient-reported outcomes - Muscle cramps

    Patient reported outcomes using a muscle cramps question.

    Time frame: Week 4

  15. Patient-reported outcomes - Muscle cramps

    Patient reported outcomes using a muscle cramps question.

    Time frame: Week 5

  16. Adverse effects

    Adverse effects based on symptoms and weekly bloodwork.

    Time frame: Week 1

  17. Adverse effects

    Adverse effects based on symptoms and weekly bloodwork.

    Time frame: Week 2

  18. Adverse effects

    Adverse effects based on symptoms and weekly bloodwork.

    Time frame: Week 3

  19. Adverse effects

    Adverse effects based on symptoms and weekly bloodwork.

    Time frame: Week 4

  20. Adverse effects

    Adverse effects based on symptoms and weekly bloodwork.

    Time frame: Week 5

  21. Urine furosemide levels

    Urine furosemide levels from weekly urine samples

    Time frame: Week 3

  22. Urine furosemide levels

    Urine furosemide levels from weekly urine samples

    Time frame: Week 4

  23. Urine furosemide levels

    Urine furosemide levels from weekly urine samples

    Time frame: Week 5

07

Study locations

1 site
  • University of Alberta
    Edmonton, Alberta T6G 2B7, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05915286
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Jun 22, 2023
Start date
May 29, 2023
Primary completion
Feb 21, 2025
Completion
Feb 21, 2025
Last update
May 8, 2026

Study contacts

Branko Braam, MD/Ph.D.
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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