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The Relation Between the Renal Resistive Index and Glomerular Hyper Filtration

2016年5月9日 更新者:H.M. Oudemans-van Straaten, MD, PhD、Amsterdam UMC, location VUmc

Relation Between Renal Resistive Index, Glomerular Hyperfiltration and Hyperdynamic Circulation in Critically Ill Patients With Trauma or Sepsis.

Aim of the present study is to determine whether

  1. RRI can predict glomerular hyperfiltration;
  2. glomerular hyperfiltration is associated with low renal resistive index;
  3. glomerular hyperfiltration/low RRI are associated with accelerated flow in the sublingual microcirculation;
  4. glomerular hyperfiltration/low RRI are related to fluid status as quantified with bioimpedance analysis.

研究概览

地位

完全的

条件

详细说明

Apart from acute kiddney injury (AKI), critically ill patients with sepsis or trauma can also exhibit glomerular hyperfiltration (2-4). Glomerular hyperfiltration is not easily recognized, because the decrease in serum creatinine is a late manifestation and generally interpreted as normal renal function. Glomerular hyperfiltration may have clinical consequences, because it leads to augmented renal clearance of water soluble drugs. This is especially relevant for antibiotics, because augmented clearance can lead to underdosing and therapeutic failure (5-9). Patients with glomerular hyperfiltration are generally younger patients with less severe disease (3) and often exhibit a hyperdynamic circulation. The mechanism of glomerular hyperfiltration is poorly understood. High catecholamine release with increased renal blood flow could play a role. Direct measurement of renal blood flow is not available in daily clinical practice.

Nowadays, the investigators can measure Renal Resistive Index (RRI) using renal Doppler ultrasound. The RRI is a sonographic index assessing resistance of the intrarenal arcuate or interlobar arteries and is normally used to assess renal arterial disease. The method has now become available at the bedside in the intensive care unit. RRI is calculated as: (peak systolic velocity - end diastolic velocity)/peak systolic velocity. Normal values are between 0.60 and 0.70. A mean value of 0.72 has been found in critically ill patients admitted to the intensive care unit (personal data).

The investigators hypothesize that high glomerular filtration rate as measured with creatinine clearance is associated with a low renal resistive index and accelerated microvascular blood flow.

To prove or reject this hypothesis, the following study measurements will be performed in critically ill patients with sepsis or trauma:

  1. Renal ultrasound to measure renal resistive index (RRI) After visualising the kidney in ultrasound mode, checking for (chronic) renal damage, an arcuate or interlobar artery will be localized and three successive Doppler measurements at different positions in the kidney (high, middle and low) will be performed. This will be repeated 3 times in each kidney. So a total number of 9 RRI values will be obtained in each kidney.
  2. Sublingual microcirculation using Sidestream Dark Field imaging (SDF) After removal of secretions with a gauze, the device will be applied below the tongue and three sequences of about 20 seconds from adjacent areas will be recorded and stored. The investigators will measure the perfused vessel density (PVD), the proportion of perfused vessels (PPV) and the microvascular flow index (MFI) for small vessels. Each image will be divided into four quadrants, and the predominant type of flow (0 = absent, 1 = intermittent, 2 = sluggish, 3 = normal, 4 = high) will be evaluated in each quadrant. The mean of the four quadrants will be used for analysis.
  3. To assess fluid status, Bioelectrical impedance analysis (BIA) will be performedusing the Akern BIA 101 device.

BIA measures Resistance (R) and Reactance (Xc) reflecting extracellulair (R) and cellular (Xc) resistance to an alternating current of 400 μA with afrequency of 50 kHz. In previous studies the investigators found that (changes in) R are highely correlation with (changes in) fluid status.

研究类型

观察性的

注册 (实际的)

40

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Noord-Holland
      • Amsterdam、Noord-Holland、荷兰、1081 HV
        • VU Medical Center

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

有资格学习的性别

全部

取样方法

概率样本

研究人群

Adult patients, admitted to the intensive or medium care unit with sepsis or trauma

描述

Inclusion Criteria:

  • Admission to the intensive or medium care unit
  • Sepsis or trauma
  • Age > 18 years

Exclusion Criteria:

Patients

  • with chronic renal insufficiency (eGFR < 30 ml)
  • with renal transplant kidney
  • on chronic dialysis

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
Patients with sepsis or trauma
Adult patients, admitted to the intensive or medium care unit with sepsis or trauma

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Renal Resistive Index (RRI)
大体时间:1 week
1 week

次要结果测量

结果测量
大体时间
4-h Creatinine clearance
大体时间:1 week
1 week
Microvascular flow index of the sublingual microcirculation
大体时间:1 week
1 week
Resistance, as measured with bioimpedance as a marker of fluid status.
大体时间:1 week
1 week

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:Heleen M. Oudemans, Prof. Dr.、Amsterdam UMC, location VUmc

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。

一般刊物

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

2015年8月1日

初级完成 (实际的)

2016年1月1日

研究完成 (实际的)

2016年2月1日

研究注册日期

首次提交

2015年9月22日

首先提交符合 QC 标准的

2015年9月24日

首次发布 (估计)

2015年9月25日

研究记录更新

最后更新发布 (估计)

2016年5月10日

上次提交的符合 QC 标准的更新

2016年5月9日

最后验证

2016年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • METC-2014.563

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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