Recruiting

Furosemide

Sponsor:

Unity Health Toronto

Code:

NCT01815892

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Withdrawal of furosemide

furosemide administration

Study Details

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.

Conditions

End Stage Renal Disease

Study ID

NCT01815892

Start date

May, 2015

Status verified date

Aug, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:all patients taking Furosemide -

Exclusion Criteria:Patients not willing to give consent

-

Study Design

Enrollment

51 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Withdrawal of Furosemide

The patient's Furosemide will be withdrawn

experimental: Administration of furosemide

The patient will receive furosemide 120 mgms daily

Interventions

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

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.

Primary outcome measure

  • 24 hour urine sodium and water excretion [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Marc B Goldstein, MD

416 864 5290goldsteinma@smh.ca

Locations

St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Marc B Goldstein, MD

416 864 5290goldsteinma@smh.ca

Principal Investigator:

Marc B Goldstein, MD

More Information

Sponsor

Unity Health Toronto

Last update posted

Aug 10, 2016

Last verified

Aug, 2016

Keywords

  • Hemodialysis
  • Response to Furosemide

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2016-08-10.