Monitoring Renal Blood Flow Using Contrast Enhanced Ultrasound in Predicting Acute Kidney Injury After Exposure to Iodinated Contrast Agent
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Acute Kidney Injury
研究概览
简要总结
Contrast induced nephropathy (CN) is a common cause of acute kidney injury and is associated with increased morbidity and mortality and healthcare cost. Iodinated contrast media (ICM) induce kidney injury through vasoconstriction and ischemia as well as direct tubular toxicity. Older subjects, individuals with preexisting kidney disease, diabetes, hypotension, and those exposed to higher volumes of ICM are at higher risks for CN. Within the last several years, multiple strategies have been used in clinical studies to reduce the risk of CN in high risk individuals with inconsistent results. In general, it is agreed that volume expansion is effective in reducing the risk. However, no study has looked at changes in renal blood flow (RBF) in response to volume expansion or after exposure to ICM to investigate its relationship with occurrence of CN.
In this proposal, up to 125 individuals with preexisting kidney disease as evidenced by an estimated glomerular filtration rate (eGFR) between 30 - 60 ml/min/1.73 m2 and up to 25 individuals with normal renal function (total of up to 150 individuals) who are scheduled for coronary angiography will be studied. Each individual will have serial measurements of RBF; at baseline, after volume expansion with normal saline, and after exposure to ICM, using the novel technique of contrast enhanced ultrasound (CEU). The investigators will investigate the utility of monitoring RBF with CEU in predicting the occurrence of CN (a rise of > 0.3 mg/dL or 25% in baseline serum creatinine 48 hours after exposure to ICM) after adjusting for other known risk factors in the group of subjects with reduced GFR. The investigators will also examine the correlation between RBF changes and other urinary and serum biomarkers of kidney injury in this group. Up to 25 individuals with a normal kidney function will be studied in a separate part of the study in which the accuracy of CEU based measurements of RBF will be compared to the RBF and blood flow velocity obtained simultaneously using a Doppler flow probe placed directly inside the main renal artery during coronary angiogram procedure. Total to enroll = 150.
详细描述
What will be done in this protocol? Specific to Aim 1: To investigate the correlation between changes in RBF after exposure to iodinated contrast agent, measured by CEU, on occurrence of acute kidney injury (AKI) in a population of subjects at risk for CN.
Procedures: Subjects with an estimated glomerular filtration rate (eGFR), measured by the Modification of Diet in Renal Disease (MDRD) formula, between 30 - 60 ml/min/1.73 m2 who are scheduled for a coronary angiogram will be enrolled in this study. These subjects are considered to be at higher risks of CN. It is important to clarify that all subjects are scheduled for a coronary angiography for clinical reasons before enrollment in this study. Coronary angiography is not a part of interventions of this protocol. The decision regarding the need for coronary angiography and the strategies for its prevention are made by the subjects' healthcare providers and not the research team.
The details of protocol will be discussed with all interventional cardiologists and permission will be obtained to discuss study details with potential subjects. Eligible subjects will be identified by searching the electronic medical record of individuals who are listed in the cardiac catheterization laboratory schedule for inclusion and exclusion criteria. Subjects who appear to qualify for study participation based on medical record review the inclusion and exclusion criteria will be approached. The details of the study goals, procedures and risks will be discussed with each individual and questions will be answered. The subjects will then be asked to sign the informed consent form. They will then be enrolled in the study.
Since undergoing an X-ray examination or exposure to iodinated contrast media are contraindicated in pregnancy, we assume all women of child bearing age having a test to rule out pregnancy before enrolling in the study. If this test is not done, we will contact the subject's cardiologist and arrange for it as a part of clinical care and not a research related procedure.
At the time of enrollment data on subjects' age, race, gender, ethnicity, history of coronary artery disease, diabetes and congestive heart failure will be collected. Subjects with a history of heart failure will be asked about presence of symptoms of heart failure such as shortness of breath at rest or with activities, fatigue, palpitation and dyspnea. This information will be used to identify the New York Heart Association (NYHA) class of heart failure which is considered a risk factor for CN. List of medications used by subjects will also be recorded. Vital signs will be recorded.
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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Contrast Enhanced Ultrasound
Renal blood flow before and after exposure to iodinated contrast agent (perflutren) also known as Definity will be measured using contrast enhanced ultrasound (CEUS).
干预措施: perflutren (Drug)
结局指标
主要结局
Acute Kidney Injury
时间窗: 24 - 72 hours
Correlation between changes in renal blood flow measured by contrast ultrasound and occurrence of AKI.
次要结局
- Change in novel biomarkers of AKI(24 - 72 hours)
