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临床试验/NCT02417883
NCT02417883Unknown3 期

Furosemide Stress Test as a Predictor of Tubular Atrophy and Interstitial Fibrosis in Patients With Chronic Kidney Disease

Instituto Nacional de Cardiologia Ignacio Chavez1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
发起方
入组人数
100
试验地点
1
主要终点
Urinary Output

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Furosemide (Drug)

结局指标

主要结局

Urinary Output

时间窗: 6 hours

Cuantify urinary output after furosemide administration

次要结局

  • Furosemide excretion rate(6hrs)
  • Interstitial Fibrosis(3 days)

研究者

发起方
Instituto Nacional de Cardiologia Ignacio Chavez
申办方类型
Other
责任方
Principal Investigator
主要研究者

Magdalena Madero

Chief of Nephrology Department, MD

Instituto Nacional de Cardiologia Ignacio Chavez

研究点 (1)

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