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The Use of Furosemide in Patients on Dialysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01815892
Recruitment Status : Unknown
Verified August 2016 by Unity Health Toronto.
Recruitment status was:  Recruiting
First Posted : March 21, 2013
Last Update Posted : August 10, 2016
Information provided by (Responsible Party):
Unity Health Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Withdrawal of furosemide Drug: furosemide administration Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Determinants of the Effectiveness of the Use of Furosemide in Patients on Dialysis
Study Start Date : May 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Furosemide

Arm Intervention/treatment
Active Comparator: Withdrawal of Furosemide
The patient's Furosemide will be withdrawn
Drug: Withdrawal 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
Other Name: Lasix

Experimental: Administration of furosemide
The patient will receive furosemide 120 mgms daily
Drug: furosemide 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.
Other Name: lasix

Primary Outcome Measures :
  1. 24 hour urine sodium and water excretion [ Time Frame: 2 weeks ]
    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

Secondary Outcome Measures :
  1. Interdialytic weight gain [ Time Frame: 2 weeks ]
    The interdialytic weight gain on and off the drug will be compared

Other Outcome Measures:
  1. The patients' BP on and off the drug will be compared [ Time Frame: 2 weeks ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:all patients taking Furosemide -

Exclusion Criteria:Patients not willing to give consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01815892

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Contact: Marc B Goldstein, MD 416 864 5290

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Canada, Ontario
St Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Marc B Goldstein, MD    416 864 5290   
Principal Investigator: Marc B Goldstein, MD         
Sponsors and Collaborators
Unity Health Toronto
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Principal Investigator: Marc B Goldstein, MD Unity Health Toronto
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Responsible Party: Unity Health Toronto Identifier: NCT01815892    
Other Study ID Numbers: MBG1234
First Posted: March 21, 2013    Key Record Dates
Last Update Posted: August 10, 2016
Last Verified: August 2016
Keywords provided by Unity Health Toronto:
Response to Furosemide
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action