- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01815892
The Use of Furosemide in Patients on Dialysis
The Determinants of the Effectiveness of the Use of Furosemide in Patients on Dialysis
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Marc B Goldstein, MD
- Phone Number: 416 864 5290
- Email: goldsteinma@smh.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- St Michael's Hospital
-
Contact:
- Marc B Goldstein, MD
- Phone Number: 416 864 5290
- Email: goldsteinma@smh.ca
-
Principal Investigator:
- Marc B Goldstein, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:all patients taking Furosemide -
Exclusion Criteria:Patients not willing to give consent
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Withdrawal of Furosemide
The patient's Furosemide will be withdrawn
|
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 Names:
|
Experimental: Administration of furosemide
The patient will receive furosemide 120 mgms daily
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interdialytic weight gain
Time Frame: 2 weeks
|
The interdialytic weight gain on and off the drug will be compared
|
2 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc B Goldstein, MD, Unity Health Toronto
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Membrane Transport Modulators
- Diuretics
- Sodium Potassium Chloride Symporter Inhibitors
- Furosemide
Other Study ID Numbers
- MBG1234
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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