CClinicalTrials.gg
Status unknownNCT01815892Updated Aug 10, 2016

The Use of Furosemide in Patients on Dialysis

A Phase 4 interventional study of Withdrawal of furosemide and furosemide administration in End Stage Renal Disease, sponsored by Unity Health Toronto. Status unknown at 1 site in Canada. Per ClinicalTrials.gov, last updated 2016-08-10.

Sponsored by Unity Health Toronto · Phase 4, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Sex
All
01

Study summary

Patients often begin dialysis taking diuretics (stimulate the kidney to excrete salt and water). Once on dialysis, these drugs are often continued. Whether these drugs are still needed, or even effective is often unclear.This study,by evaluating the composition of the patients' urine when off the drug, will predict which patients should benefit from the drug. By comparing their 24 hour volume both off and on the drug, the impact of the drug will be established. The results will allow the prediction of which patients, in the future, should take the drug. The hypothesis is: Among dialysis recipients, evaluation of the random urine sodium concentration will help predict the likelihood of a positive response to Furosemide, as manifested by an increased urine volume and sodium excretion.

Read the detailed description

Patients often begin dialysis on a significant dose of diuretic due to the retention of sodium and water in the predialysis phase of their chronic kidney disease (CKD). The quandary often faced by the care team is whether or not the diuretic should be continued on dialysis, particularly after they have been on dialysis for a period of time. For the appropriate dialysis patient, a daily dose of furosemide,, minimizes the interdialytic weight gain, may result in better blood pressure (BP) control and may lower the risk of heart failure. Furthermore, there may be a favourable impact on cardiac remodeling and cardiac morbidity and mortality. The diuretic may also increase the excretion of potassium, thereby reducing the likelihood of hyperkalemia.

Patients with significant renal sodium reabsorption would be the ones who would be expected to respond to furosemide. Thus patients whose urine [Na] is less than 80 mM are reabsorbing significant amounts of filtered Na (glomerular filtrate [Na] would be between 130 and 140mM) and thus might be expected to respond to furosemide. (This is premised on the assumption that the urine [Na] does not vary much during the day in chronic dialysis recipients, but this will be established during the course of the study.)

The patients Dry Weight will be optimized prior to entry into study according to usual care: this involves integrating BP data, the central venous pressure as assessed by the internal jugular vein, and patient symptoms (eg,dyspnea during the interdialytic interval,prolonged lightheadedness/presyncope/fatigue after dialysis)..

Patients on dialysis who are taking furosemide will be asked to stop their furosemide for 2 weeks, and their dry weight maintained with ultrafiltration on dialysis alone.

After 2 weeks, to establish whether there is any diurnal variation in the urine [Na] they will collect their urine in separate containers, appropriately labeled with the date and time, during the 24 hr period ending pre dialysis after the long interdialytic interval. These collections will also determine whether there is any diurnal variation in [Na], the individual urine [Na], as well as indicate the 24 hour urine volume and Na excretion off the furosemide.

All urine samples will be assayed for the concentration of Na, K, and creatinine, as well as their volume.

Thereafter, each patient will be given furosemide 120 mgm every morning for 2 weeks and they will collect the urine voided with each voiding (labeling with the time voided) in separate containers during the 24 hr period ending pre dialysis after the long interdialytic interval after 2 weeks . These collections will answer whether there is any diurnal variation in [Na] while on furosemide, as well as determine the 24 hour urine volume and Na excretion on the furosemide.

The results will determine whether those patients taking furosemide are indeed benefitting from it (Na, K and H2O excretion) and will help one to predict whether patients not taking furosemide, might indeed benefit from taking it.

At the conclusion of the 2-week period of furosemide therapy, the patient's primary nephrologist will determine the need for continuing this agent and if a decision is made to continue furosemide, the dose would be at the discretion of the nephrologist.

The primary outcome is the increase in urine volume and 24 hour sodium excretion in response to the furosemide therapy

02

Conditions studied

  • End Stage Renal Disease

Keywords

  • Hemodialysis
  • Response to Furosemide
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's planned enrollment of 51 is close to the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:all patients taking Furosemide -

Exclusion Criteria:Patients not willing to give consent

-

05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
51 participants (estimated)

Study arms

  • Active comparator
    Withdrawal of Furosemide

    The patient's Furosemide will be withdrawn

    Drug: Withdrawal of furosemide

  • Experimental
    Administration of furosemide

    The patient will receive furosemide 120 mgms daily

    Drug: furosemide administration

Interventions

  • DrugWithdrawal of furosemide

    The patient (previously on furosemide) will have the furosemide stopped for 2 weeks. The interdialytic weight gain, BP and 24 hour urine volume and sodium excretion will be measured

    Also known as: Lasix

  • Drugfurosemide administration

    The patient will receive 120 mgm furosemide daily for 2 weeks and the interdialytic weight gain, BP and 24 hr urine volume and sodium excretion will be measured.

    Also known as: lasix

06

What researchers measure

Primary outcomes

  1. 24 hour urine sodium and water excretion

    The patients 24 hour sodium and water excretion on and off the medication (which they had already been taking) will be compared for effectiveness of the drug. The hypothesis is that the urine sodium concentration off the drug, will predict the response and thus be of diagnostic value for other patients

    Time frame: 2 weeks

Secondary outcomes

  1. Interdialytic weight gain

    The interdialytic weight gain on and off the drug will be compared

    Time frame: 2 weeks

Other outcomes

  1. The patients' BP on and off the drug will be compared

    The patients pre dialysis BP as well as the 48 hr ambulatory BP (if the patient is willing) will be compared in both phases of the study.

    Time frame: 2 weeks

07

Study locations

1 of 1 sites recruiting
  • St Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
    • Marc B Goldstein, MD · Contact · goldsteinma@smh.ca · 416 864 5290
    • Marc B Goldstein, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01815892
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Mar 21, 2013
Start date
May 2015
Primary completion
Dec 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Aug 10, 2016

Study contacts

Marc B Goldstein, MD
Contact
goldsteinma@smh.ca
416 864 5290
Marc B Goldstein, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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