Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease (FST-IFTA)
Primary Purpose
Chronic Kidney Disease
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Furosemide
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Kidney Disease focused on measuring Furosemide, Interstitial Fibrosis
Eligibility 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
Sites / Locations
- Instituto Nacional de Cardiologia Ignacio ChavezRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Furosemide Stress Test
Arm Description
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.
Outcomes
Primary Outcome Measures
Urinary Output
Cuantify urinary output after furosemide administration
Secondary Outcome Measures
Furosemide excretion rate
Cuantify furosemide excretion in urine
Interstitial Fibrosis
Measure interstitial fibrosis in kidney biopsy
Full Information
NCT ID
NCT02417883
First Posted
April 13, 2015
Last Updated
April 13, 2015
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
1. Study Identification
Unique Protocol Identification Number
NCT02417883
Brief Title
Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease
Acronym
FST-IFTA
Official Title
Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2016 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Furosemide, Interstitial Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Furosemide Stress Test
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Furosemide
Intervention Description
Evaluate urinary excretion rate fo furosemide
Primary Outcome Measure Information:
Title
Urinary Output
Description
Cuantify urinary output after furosemide administration
Time Frame
6 hours
Secondary Outcome Measure Information:
Title
Furosemide excretion rate
Description
Cuantify furosemide excretion in urine
Time Frame
6hrs
Title
Interstitial Fibrosis
Description
Measure interstitial fibrosis in kidney biopsy
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena Madero, MD
Phone
+55-5573-2911
Ext
1262
Email
madero.magdalena@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos A Garza, MD
Phone
+55-5573-2911
Ext
1262
Email
gza.carlos@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Organizational Affiliation
Chief of the Nephrology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Nacional de Cardiologia Ignacio Chavez
City
Mexico city
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdalena Madero, MD
Email
madero.magdalena@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
20838416
Citation
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.
Results Reference
background
PubMed Identifier
17587828
Citation
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. doi: 10.1159/000101323.
Results Reference
background
PubMed Identifier
24712330
Citation
Farris AB, Chan S, Climenhaga J, Adam B, Bellamy CO, Seron 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.
Results Reference
background
PubMed Identifier
22449945
Citation
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.
Results Reference
background
PubMed Identifier
25033085
Citation
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. No abstract available.
Results Reference
background
PubMed Identifier
24053972
Citation
Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
Results Reference
result
PubMed Identifier
32143585
Citation
Rivero J, Rodriguez F, Soto V, Macedo E, Chawla LS, Mehta RL, Vaingankar S, Garimella PS, Garza C, Madero M. Furosemide stress test and interstitial fibrosis in kidney biopsies in chronic kidney disease. BMC Nephrol. 2020 Mar 6;21(1):87. doi: 10.1186/s12882-020-01721-z.
Results Reference
derived
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Furosemide Stress Test as a Predictor of Tubular Function in Chronic Kidney Disease
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