End Stage Renal DiseasePhase 4NCT01815892
The Use of Furosemide in Patients on Dialysis
A Phase 4 study testing Withdrawal of furosemide and furosemide administration in people with End Stage Renal Disease, run by Unity Health Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Withdrawal of furosemide and furosemide administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- May 2015to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Marc B Goldstein, MD, 416 864 5290, goldsteinma@smh.ca
Marc B Goldstein, MD
About this study
Official title: The Determinants of the Effectiveness of the Use of Furosemide in Patients on Dialysis
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
- Conditions
- End Stage Renal Disease
- Being tested
- Withdrawal of furosemide, furosemide administration
- Keywords
- Hemodialysis, Response to Furosemide
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal of furosemideDrug
Also called Lasix
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
furosemide administrationDrug
Also called lasix
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.
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal of Furosemide | Active comparator | The patient's Furosemide will be withdrawn Receives: Drug: Withdrawal of furosemide |
| Administration of furosemide | Experimental | The patient will receive furosemide 120 mgms daily Receives: Drug: furosemide administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Secondary outcomes (1)
Interdialytic weight gain
The interdialytic weight gain on and off the drug will be compared
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2013 (estimated)
- Study startMay 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc B Goldstein, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815892
- Sponsor's protocol ID
- MBG1234
- Status last verified
- Aug 2016
- First submitted
- 19 Mar 2013
- Last updated
- 10 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Determinants of the Effectiveness of the Use of Furosemide in Patients on Dialysis
- ClinicalTrials.gov ID
- NCT01815892
- Acronym / sponsor ID
- MBG1234
- Conditions
- End Stage Renal Disease
- Keywords
- Hemodialysis, Response to Furosemide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withdrawal of Furosemide | Active comparator | Drug: Withdrawal of furosemideThe patient's Furosemide will be withdrawn |
| Administration of furosemide | Experimental | Drug: furosemide administrationThe patient will receive furosemide 120 mgms daily |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withdrawal of furosemideAlso: LasixThe 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 | Drug | Withdrawal of Furosemide |
| furosemide administrationAlso: lasixThe 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. | Drug | Administration of furosemide |
Primary outcome
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
1 secondary outcome
Interdialytic weight gain
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc B Goldstein, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Withdrawal of furosemide and furosemide administration in people with End Stage Renal Disease, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc B Goldstein, MD (416 864 5290, goldsteinma@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour urine sodium and water excretion (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2016.