Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Contrast Induced Acute Kidney Injury |
Drug: Contrast Enhanced Ultrasound (CEUS) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Monitoring Renal Blood Flow Using Contrast Enhanced Ultrasound in Predicting Acute Kidney Injury After Exposure to Iodinated Contrast Agent |
- Acute Kidney Injury [ Time Frame: 24 - 72 hours ] [ Designated as safety issue: Yes ]Correlation between changes in renal blood flow measured by contrast ultrasound and occurrence of AKI.
- Change in novel biomarkers of AKI [ Time Frame: 24 - 72 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Contrast Enhanced Ultrasound
Renal blood flow before and after exposure to iodinated contrast agent will be measured using contrast enhanced ultrasound (CEUS) using Definity.
|
Drug: Contrast Enhanced Ultrasound (CEUS)
CEUS is performed during continuous intravenous infusion of Definity (drug) to assess changes in renal blood flow during the study
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult (> 18 years of age) men and women
- All races and ethnicities
- Chronic kidney disease stage 3 with an estimated GFR by MDRD formula between 30 - 59 ml/min/1.73 m2
- Being scheduled for a coronary angiography study as part of their clinical care
Exclusion Criteria:
- Estimated GFR greater than 60 or below 30 ml/min/1.73 m2
- History of kidney transplantation
- Known history of a right to left intracardiac shunt
- Pregnancy or lactation
- History of allergies to Definity®
Contacts and Locations| Contact: Kambiz Kalantari, MD, MS | 434-924-5125 | kk6c@virginia.edu |
| United States, Virginia | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Kambiz Kalantari, MD 434-924-5820 kk6c@virginia.edu | |
| Contact: Sharon L Johnson, CRC 434-924-5802 slj3b@virginia.edu | |
| Principal Investigator: Kambiz Kalantari, MD, MS | |
| Sub-Investigator: Michael Ragosta, MD | |
| University of Virginia Health System | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
More Information
No publications provided
| Responsible Party: | University of Virginia |
| ClinicalTrials.gov Identifier: | NCT01544036 History of Changes |
| Other Study ID Numbers: | 15591, K23DK074616 |
| Study First Received: | February 27, 2012 |
| Last Updated: | March 2, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of Virginia:
|
AKI contrast nephropathy renal blood flow |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013