External Validation of IRRIV Test Relationship With Renal Functional Reserve (IRRIV-RFR)
2018年11月27日 更新者：Sara Samoni、Ospedale San Bortolo di Vicenza
The Relationship Between IRRIV and RFR Under Normal Conditions: External Validation
The assessment of renal functional reserve (RFR) has been proposed for the risk stratification of patients undergoing potentially nephrotoxic procedures.
The investigators hypothesized that there is a correlation between IRRIV and RFR under normal conditions.
For this purpose, externally validation of IRRIV test is performed in a validation cohort of healthy subjects.
研究概览
地位
完全的
条件
详细说明
Normal subjects display a significant capacity to increase in baseline GFR under physiological needs (e.g.
pregnancy) or pathological states (e.g.
solitary kidney).
This capacity is known as renal functional reserve (RFR), and it is calculated as the difference between the measured maximum GFR achieved through a renal stress test and the baseline GFR measured in rest conditions.In clinical practice, the most common renal stress test is performed as a standardized protein loading test.
In a pilot study, the investigators demonstrated a significant correlation between RFR and the intra-parenchymal renal resistive index variation (IRRIV) during an echo renal stress test in a cohort of healthy volunteers.
IRRIV test has proven to be rapid, safe, bedside and easy to perform and it might represent a preliminary test in screening patients' RFR.
For this purpose, externally validation of IRRIV test is performed in a validation cohort of healthy subjects.
研究类型
观察性的
注册 (实际的)
47
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Healthy subjects undergoing a protein loading and IRRIV test evaluation
描述
Inclusion criteria were:
- Age more than 18 years old;
- Baseline estimated GFR, calculated using the chronic kidney disease epidemiology collaboration (CKD-EPI) equation, greater than or equal to 60 ml/min/1.73 m2.
Exclusion criteria were:
- Age less than 18 years old;
- Comorbidities potentially affecting renal function (i.e. arterial hypertension, diabetes, vasculopathy, etc.;
- Chronic administration of drugs able to modify renal blood flow and/or GFR (angiotensin converting enzyme-inhibitors (ACEI), angiotensin receptor blockers (ARB), calcium channel blockers, loop diuretics etc.);
- Pregnancy;
- Ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis;
- Nonsteroidal anti-inflammatory drugs (NSAIDs) or contrast media in the 2 days before the tests.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Healthy Subjects
All subjects underwent protein loading test and IRRIV test on the same day.
The renal resistive index (RRI) measurements were performed by one trained sonographer using a multi-frequency convex probe through a manual RRI calculations.
The RRIs were measured on three interlobular arteries (superior, middle and inferior) in each kidney, and expressed as a mean value.
RFR was measured using an oral protein loading test and was then defined as the difference between the highest CrCl obtained after the protein load and the baseline CrCl measured on rest conditions.
Urinary creatinine and sCr were measured by the enzymatic method (IL testTM Instrumentation(R), Laboratory SpA, Milano, Italy) and by ILab650 (Instrumentation Laboratory, Werfen Group, Barcelona, Spain).
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Externally validate IRRIV test
大体时间：Change from baseline to 60 minutes
|
A weight of 10% of the patient's body weight was applied on the abdomen.
RRIs were recorded in a middle interlobular artery, every minute for 10 minutes during the echo-renal stress test.
The lowest RRI reached was taken as reference (stress RRI).
The IRRIV was defined as the percentage difference between baseline RRI and stress RRI.
|
Change from baseline to 60 minutes
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation between IRRIV test and RFR
大体时间：Change from baseline to 60 minutes
|
Correlation between IRRIV and RFR is tested through a Pearson analysis.
Concordance between presence of RFR (i.e. a RFR≥15ml/min/1.73m2)
and a positive/uncertain/negative IRRIV is evaluated.
|
Change from baseline to 60 minutes
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Claudio Ronco, MD、Ospedale San Bortolo di Vicenza
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年9月2日
初级完成 (实际的)
2015年11月30日
研究完成 (实际的)
2016年1月10日
研究注册日期
首次提交
2018年11月26日
首先提交符合 QC 标准的
2018年11月26日
首次发布 (实际的)
2018年11月28日
研究记录更新
最后更新发布 (实际的)
2018年11月29日
上次提交的符合 QC 标准的更新
2018年11月27日
最后验证
2018年11月1日
更多信息
与本研究相关的术语
其他研究编号
- 0103/15
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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