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

NCT02417883 | Unknown Phase 3 DMC

• 1 other identifier: PT15-920
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

Furosemide; Interstitial Fibrosis

Outcome Measures

Primary Outcomes (1)

• Urinary Output

  Cuantify urinary output after furosemide administration

  6 hours

Secondary Outcomes (2)

• Furosemide excretion rate

  6hrs

• Interstitial Fibrosis

  3 days

Study Arms (1)

Furosemide Stress Test

EXPERIMENTAL

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

Interventions

Furosemide DRUG

Evaluate urinary excretion rate fo furosemide

Furosemide Stress Test

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiologia Ignacio Chavez

Mexico City, Mexico City, 14080, Mexico

RECRUITING

Related Publications (7)

• 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.

  PMID: 20838416 BACKGROUND

• 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.

  PMID: 17587828 BACKGROUND

• 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.

  PMID: 24712330 BACKGROUND

• 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.

  PMID: 22449945 BACKGROUND

• 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.

  PMID: 25033085 BACKGROUND

• 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.

  PMID: 24053972 RESULT

• 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.

  PMID: 32143585 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Pulmonary Fibrosis

Interventions

Furosemide

Condition Hierarchy (Ancestors)

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; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

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

Study Officials

• Magdalena Madero, MD

  Chief of the Nephrology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Madero, MD

CONTACT

+55-5573-2911; madero.magdalena@gmail.com

Carlos A Garza, MD

CONTACT

+55-5573-2911; gza.carlos@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Nephrology Department, MD

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2017
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

ME (1)