此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Use of Transesophageal Echocardiography to Measure Intraoperative Renal Resistive Index and Predict Acute Renal Injury

2015年4月23日 更新者:Rutgers, The State University of New Jersey
The investigators hypothesize that transesophageal echocardiography is a valid method to obtain renal doppler hemodynamics2, 4. The goal of this study is to determine if there is a correlation between abnormal TEE resistive index measurements, intraoperative events and post-operative creatinine changes

研究概览

详细说明

The significant morbidity and mortality associated with acute kidney injury in critical care patients and after cardiac surgery is well-known. Studies have demonstrated between 1 to 30% postoperative mortality and even higher rates of up to 70% when patients develop renal failure and require dialysis. Even small increases in creatinine between 0 to 0.5 mg/dl can result in a greater than two-fold rise in 30-day mortality.1 Despite efforts to improve outcome, there has been no proven effective pharmacological interventions to treat acute kidney failure. Most recommendations are aimed at prevention by identifying high-risk patients, avoiding nephrotoxic drugs and minimizing intraoperative hypotensive insults.2

There are few studies that have examined the maintenance of adequate renal perfusion by measuring renal blood flow using transesophageal echocardiography (TEE) during cardiopulmonary bypass.3, 4 Yang et al. examined the left renal artery of 60 patients using TEE during cardiac surgery and evaluated the feasibility of using TEE as a method to measure renal blood flow intraoperatively.4 Although they were only able to include 60% of the subjects due to technical difficulties, they did demonstrate less than 10% variability between measurements and therefore good reproducibility using TEE. However, renal blood flow may not be the best method to predict sufficient renal perfusion. Renal autoregulation is not preserved under general anesthesia even with the maintenance of adequate mean arterial blood pressure and cardiac output. Renal blood flow is further worsened by hemodilution and hypothermia. In addition, due to its pulsatile nature, the diameters of the renal arteries vary during the cardiac cycle and are a source of calculation error when determining renal blood flow as a function of renal blood velocity and arterial diameter.2

Renal resistive index (RI) is a measure of intrarenal hemodynamics that is calculated using the blood flow velocities of segmental or intrarenal vessels and correlates with renal blood flow and renovascular resistance. The renal artery is not used because the flow varies and is inconsistent between systole and diastole. RI becomes elevated in pathological conditions and is associated with increasing creatinine, renal injury and dysfunction.5-7 As blood flow and creatinine clearance decrease through the renal vasculature, the resistive index increases. Resistive index may be a better gauge of renal dysfunction rather than renal blood flow because it is easier to assess and less dependent on obtaining a Doppler beam view that is oriented perfectly parallel to the blood flow.2 Because RI is a ratio of the renal blood flow velocities [RI = (peak systolic velocity - peak end diastolic velocity)/peak systolic velocity], the margin of error created by non-parallel Doppler beams cancels out.

Traditionally, resistive index is obtained by transabdominal Doppler ultrasonography (USG) although there have been transesophageal studies that have used RI as a secondary endpoint when examining renal blood flow.2, 4 There is currently no technique that routinely uses TEE to intraoperatively monitor resistive index as a determination of adequate renal blood perfusion and an indication of renal compromise.8 In addition, while other studies have reported RI as a secondary outcome, no studies have validated the TEE calculation of resistive index compared to the established transabdominal doppler technique.

研究类型

观察性的

注册 (实际的)

13

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

    • New Jersey
      • Newark、New Jersey、美国、07101
        • University Hospital

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 至 89年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

potential subjects are those undergoing cardiac or major abdominal or vascular surgery where TEE is standard of care

描述

Inclusion Criteria:

  • TEE is part of a anesthetic plan as determined by the anesthesiologist

Exclusion Criteria:

  • Subjects on hemodialysis/peritoneal dialysis
  • Subjects with a contraindication to use of TEE; esophageal stricture, esophageal diverticulum, esophageal tumor, recent esophageal/gastric surgery or radiation to the chest
  • Subjects who are pregnant
  • Subjects with esophageal varices
  • Subjects with bleeding disorders

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

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
大体时间:intraoperatively
intraoperatively

次要结果测量

结果测量
措施说明
大体时间
post operative creatinine changes
大体时间:5 days post operatively
subjects Blood Urea Nitrogen and creatinine levels will be recorded daily
5 days post operatively

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

  • 首席研究员:Douglas Jackson, MD, JD、Rutgers/NJMS

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

2011年8月1日

初级完成 (实际的)

2014年9月1日

研究完成 (实际的)

2014年9月1日

研究注册日期

首次提交

2012年3月2日

首先提交符合 QC 标准的

2012年3月6日

首次发布 (估计)

2012年3月7日

研究记录更新

最后更新发布 (估计)

2015年4月24日

上次提交的符合 QC 标准的更新

2015年4月23日

最后验证

2015年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • 0120110047

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.

订阅