The Use of Furosemide in Patients on Dialysis

NCT01815892 | Unknown Phase 4

• 1 other identifier: MBG1234
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Keywords

Hemodialysis; Response to Furosemide

Outcome Measures

Primary Outcomes (1)

• 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

  2 weeks

Secondary Outcomes (1)

• Interdialytic weight gain

  2 weeks

Other Outcomes (1)

• The patients' BP on and off the drug will be compared

  2 weeks

Study Arms (2)

Withdrawal of Furosemide

ACTIVE COMPARATOR

The patient's Furosemide will be withdrawn

Drug: Withdrawal of furosemide

Administration of furosemide

EXPERIMENTAL

The patient will receive furosemide 120 mgms daily

Drug: furosemide administration

Interventions

Withdrawal of furosemide DRUG

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

Also known as: Lasix

Withdrawal of Furosemide

furosemide administration DRUG

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.

Also known as: lasix

Administration of furosemide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Marc B Goldstein, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc B Goldstein, MD

CONTACT

416 864 5290; goldsteinma@smh.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2013
• First Posted: March 21, 2013
• Study Start: May 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 10, 2016

Record last verified: 2016-08

Locations

CA (1)