The Use of Furosemide in Patients on Dialysis
Information source: St. Michael's Hospital, Toronto
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease
Intervention: Withdrawal of furosemide (Drug); furosemide administration (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: St. Michael's Hospital, Toronto Official(s) and/or principal investigator(s): Marc B Goldstein, MD, Principal Investigator, Affiliation: St. Michael's Hospital, Toronto
Overall contact: Marc B Goldstein, MD, Phone: 416 864 5290, Email: goldsteinma@smh.ca
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.
Clinical Details
Official title: The Determinants of the Effectiveness of the Use of Furosemide in Patients on Dialysis
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: 24 hour urine sodium and water excretion
Secondary outcome: Interdialytic weight gain
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
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria: all patients taking Furosemide -
Exclusion Criteria: Patients not willing to give consent
-
Locations and Contacts
Marc B Goldstein, MD, Phone: 416 864 5290, Email: goldsteinma@smh.ca
St Michael's Hospital, Toronto, Ontario M5B 1W8, Canada; Recruiting Marc B Goldstein, MD, Phone: 416 864 5290, Email: goldsteinma@smh.ca Marc B Goldstein, MD, Principal Investigator
Additional Information
Starting date: May 2015
Last updated: May 27, 2015
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