Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease
Information source: Instituto Nacional de Cardiologia Ignacio Chavez
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease
Intervention: Furosemide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Instituto Nacional de Cardiologia Ignacio Chavez Official(s) and/or principal investigator(s): Magdalena Madero, MD, Principal Investigator, Affiliation: Chief of the Nephrology Department
Overall contact: Magdalena Madero, MD, Phone: +55-5573-2911, Ext: 1262, Email: madero.magdalena@gmail.com
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.
Clinical Details
Official title: Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease
Study design: Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Urinary Output
Secondary outcome: Furosemide excretion rateInterstitial Fibrosis
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Magdalena Madero, MD, Phone: +55-5573-2911, Ext: 1262, Email: madero.magdalena@gmail.com
Instituto Nacional de Cardiologia Ignacio Chavez, Mexico city, DF 14080, Mexico; Recruiting Magdalena Madero, MD, Email: madero.magdalena@gmail.com
Additional Information
Related publications: Boor P, Ostendorf T, Floege J. Renal fibrosis: novel insights into mechanisms and therapeutic targets. Nat Rev Nephrol. 2010 Nov;6(11):643-56. doi: 10.1038/nrneph.2010.120. Epub 2010 Sep 14. Review. Burns WC, Kantharidis P, Thomas MC. The role of tubular epithelial-mesenchymal transition in progressive kidney disease. Cells Tissues Organs. 2007;185(1-3):222-31. Review. Farris AB, Chan S, Climenhaga J, Adam B, Bellamy CO, SerĂ³n D, Colvin RB, Reeve J, Mengel M. Banff fibrosis study: multicenter visual assessment and computerized analysis of interstitial fibrosis in kidney biopsies. Am J Transplant. 2014 Apr;14(4):897-907. doi: 10.1111/ajt.12641. Epub 2014 Feb 20. Farris AB, Colvin RB. Renal interstitial fibrosis: mechanisms and evaluation. Curr Opin Nephrol Hypertens. 2012 May;21(3):289-300. doi: 10.1097/MNH.0b013e3283521cfa. Review. van der Voort PH, Boerma EC, Pickkers P. The furosemide stress test to predict renal function after continuous renal replacement therapy. Crit Care. 2014 May 14;18(3):429. doi: 10.1186/cc13871.
Starting date: April 2015
Last updated: April 13, 2015
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