Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram

NCT01544036 | Unknown

• 2 other identifiers: 15591K23DK074616
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Contrast Induced Acute Kidney Injury

Keywords

AKI; contrast nephropathy; renal blood flow

Outcome Measures

Primary Outcomes (1)

• Acute Kidney Injury

  Correlation between changes in renal blood flow measured by contrast ultrasound and occurrence of AKI.

  24 - 72 hours

Secondary Outcomes (1)

• Change in novel biomarkers of AKI

  24 - 72 hours

Study Arms (1)

Contrast Enhanced Ultrasound

EXPERIMENTAL

Renal blood flow before and after exposure to iodinated contrast agent (perflutren) also known as Definity will be measured using contrast enhanced ultrasound (CEUS).

Drug: perflutren

Interventions

perflutren DRUG

Contrast Enhanced Ultrasound is performed during continuous intravenous infusion of Definity (drug) to assess changes in renal blood flow during the study

Also known as: Definity

Contrast Enhanced Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Inclusion For specific aim 1 - Subjects with reduced kidney function 1. Adult (\>18 years of age) men and women 2. All races and ethnicities 3. Chronic kidney disease stage 3 with an estimated GFR by MDRD formula between 30 - 59 ml/min/1.73 m2 4. Being scheduled for a coronary angiography study as part of their clinical care For specific aim 2 - Subjects with normal kidney function 1. Adult (\>18 years of age) men and women 2. All races and ethnicities 3. Being scheduled for a coronary angiography study 4. Estimated GFR greater than or equal to 60 ml/min/1.73 m2 Exclusion For specific aim 1 - Subjects with reduced kidney function 1. Estimated GFR greater than 60 or below 30 ml/min/1.73 m2 2. History of kidney transplantation 3. Known history of a right to left intracardiac shunt 4. Pregnancy or lactation 5. History of allergies to Definity® 6. History of Pulmonary Hypertension For specific aim 2 - Subjects with normal kidney function 1. Estimated GFR less than 60 ml/min/1.73 m2 2. History of kidney transplantation 3. History of a right to left intracardiac shunt 4. Pregnancy or lactation 5. History of allergies to Definity® 6. History of recent major bleeding 7. History of allergy to heparin or heparin-induced thrombocytopenia 8. History of renal artery stenosis 9. Evidence of renal artery stenosis during the placement of Doppler wire in the renal artery 10. History of Pulmonary Hypertension

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Interventions

perflutren

Central Study Contacts

Kambiz Kalantari, MD, MS

CONTACT

434-924-5125; kk6c@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2012
• First Posted: March 5, 2012
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

US (2)