Monitoring Renal Blood Flow With Contrast Enhanced Ultrasound During Coronary Angiogram

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Virginia
ClinicalTrials.gov Identifier:
NCT01544036
First received: February 27, 2012
Last updated: December 18, 2013
Last verified: December 2013
  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: perflutren

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

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 (perflutren) also known as Definity will be measured using contrast enhanced ultrasound (CEUS).
Drug: perflutren
Contrast Enhanced Ultrasound is performed during continuous intravenous infusion of Definity (drug) to assess changes in renal blood flow during the study
Other Name: Definity

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544036

Contacts
Contact: Kambiz Kalantari, MD, MS 434-924-5125 kk6c@virginia.edu

Locations
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
Sponsors and Collaborators
University of Virginia
  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: December 18, 2013
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
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Contrast Media
Perflutren
Definity
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014