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Trial record 4 of 243 for:    furosemide

Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease (FST-IFTA)

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ClinicalTrials.gov Identifier: NCT02417883
Recruitment Status : Unknown
Verified April 2015 by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez.
Recruitment status was:  Recruiting
First Posted : April 16, 2015
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez

Brief Summary:
In kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. Kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. We aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Drug: Furosemide Phase 3

Detailed Description:

All patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. The latter will consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. A standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen.

After completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician.

Kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. The degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease
Study Start Date : April 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Furosemide

Arm Intervention/treatment
Experimental: Furosemide Stress Test
Furosemide stress test will be perform to patients scheduled for kidney bipsy. The test consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, along with urinary output follow up and measurement for 6 hours. The urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension.
Drug: Furosemide
Evaluate urinary excretion rate fo furosemide




Primary Outcome Measures :
  1. Urinary Output [ Time Frame: 6 hours ]
    Cuantify urinary output after furosemide administration


Secondary Outcome Measures :
  1. Furosemide excretion rate [ Time Frame: 6hrs ]
    Cuantify furosemide excretion in urine

  2. Interstitial Fibrosis [ Time Frame: 3 days ]
    Measure interstitial fibrosis in kidney biopsy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Accept to participate (informed consent)
  • Legal age or older
  • An estimated glomerular filtration rate greater than 15ml/min/1.73m2, calculated by CKD-EPI.

Exclusion Criteria:

  • Known Alergic reaction to furosemide
  • Contraindication to kidney biopsy
  • Patient already in renal replacement therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417883


Contacts
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Contact: Magdalena Madero, MD +55-5573-2911 ext 1262 madero.magdalena@gmail.com
Contact: Carlos A Garza, MD +55-5573-2911 ext 1262 gza.carlos@gmail.com

Locations
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Mexico
Instituto Nacional de Cardiologia Ignacio Chavez Recruiting
Mexico city, DF, Mexico, 14080
Contact: Magdalena Madero, MD       madero.magdalena@gmail.com   
Sponsors and Collaborators
Instituto Nacional de Cardiologia Ignacio Chavez
Investigators
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Principal Investigator: Magdalena Madero, MD Chief of the Nephrology Department

Publications of Results:
Other Publications:
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Responsible Party: Magdalena Madero, Chief of Nephrology Department, MD, Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov Identifier: NCT02417883     History of Changes
Other Study ID Numbers: PT15-920
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015
Keywords provided by Magdalena Madero, Instituto Nacional de Cardiologia Ignacio Chavez:
Furosemide
Interstitial Fibrosis
Additional relevant MeSH terms:
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Furosemide
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action