This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v. injection of iso-osmolar iodinated contrast material iodixanol (Visipaque™ Injection 320 mgI/mL), as compared with patients who received saline and underwent a non-enhanced CT (NECT) and duplex ultrasound (US) during their scheduled post-EVAR surveillance imaging.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
4
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of \>=0.3 mg/dL (\>=26.4 μmol/L) or increase to \>=150% to 200% (\>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to \>200% to 300% (\>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to \>300% (\>3.0-fold) from baseline or SCr \>=4.0 mg/dL (\>=354 μmol/L) with an acute increase of \>=0.5 mg/dL (\>=44 μmol/L) within 48 hours.
Time frame: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
AKIN Serum Creatinine Criteria for AKI- Stage 1: a SCr increase of \>=0.3 mg/dL (\>=26.4 μmol/L) or increase to \>=150% to 200% (\>=1.5- to 2.0-fold) from baseline within 48 hours. Stage 2: a SCr increase to \>200% to 300% (\>2.0- to 3-fold) from baseline within 48 hours. Stage 3: a SCr increase to \>300% (\>3.0-fold) from baseline or SCr \>=4.0 mg/dL (\>=354 μmol/L) with an acute increase of \>=0.5 mg/dL (\>=44 μmol/L) within 48 hours.
Time frame: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)
Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.
Time frame: 48 hours post-baseline (Follow-up 1)
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria
Waikar's definitions of AKI: Stage 1: 0.3 mg/dL increase in SCr over 24 hours or a 0.5 mg/dL increase in SCr over 48 hours. Stage 2: 0.5 mg/dL increase in SCr over 24 hours or a 1.0 mg/dL increase in SCr over 48 hours. Stage 3: 1.0 mg/dL increase in SCr over 24 hours or a 1.5 mg/dL increase in SCr over 48 hours.
Time frame: 48 hours post-baseline (Follow-up 1)
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University Hospital
Birmingham, Alabama, United States
: Aventiv Research Inc.
Mesa, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Alliance Research Centers
Laguna Hills, California, United States
Universal Axon Clinical Research, LLC
Doral, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
University of South Florida - South Tampa Campus
Tampa, Florida, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Hospital
Louisville, Kentucky, United States
Boston University Medical Center/Boston Medical Center
Boston, Massachusetts, United States
...and 19 more locations
All Cause Mortality and Morbidity
Mortality (all cause death) and morbidity i.e. critical events.
Time frame: From Baseline to Month 6
Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale
Blinded independent assessment of image quality/diagnostic confidence using a 5-point scale. Image quality/diagnostic confidence for all imaging studies was rated on a 5-point scale from 1 (poor) to 5 (excellent).
Time frame: Month 6