Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease

Phase 3

• Conditions: Chronic Kidney Disease
• Interventions: Drug: Furosemide

• Registration Number: NCT02417883
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2015-04
• Study Start: 2015-04
• Study First Submitted: 2015-04-13
• Study First Submitted QC: 2015-04-13
• Last Update Submitted: 2015-04-13
• Study First Posted: 2015-04-16
• Last Update Posted: 2015-04-16
• Primary Completion: 2016-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Furosemide Stress Test	Furosemide	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.

Primary Outcome Measures

Name	Time	Method
Urinary Output	6 hours	Cuantify urinary output after furosemide administration

Secondary Outcome Measures

Name	Time	Method
Furosemide excretion rate	6hrs	Cuantify furosemide excretion in urine
Interstitial Fibrosis	3 days	Measure interstitial fibrosis in kidney biopsy

Trial Locations

Locations (1)

Instituto Nacional de Cardiologia Ignacio Chavez; 🇲🇽 Mexico city, DF, Mexico