A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
- Registration Number
- NCT03119662
- Lead Sponsor
- GE Healthcare
- Brief Summary
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.
- Detailed Description
GEHC has decided not to provide this detail
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- Was ≥18 years of age at the time that written informed consent is obtained.
- Was male or is a nonpregnant, nonlactating female who is either surgically sterile or is postmenopausal. Women of childbearing potential must use adequate contraception from Screening until 30 days after the Baseline Visit and must have a negative pregnancy test at the Baseline Visit.
- Was an outpatient who has undergone successful EVAR and is scheduled for his/her next post-procedural imaging follow-up examination.
- Had previously completed one or more of his or her post-EVAR surveillance imaging examination(s) that provided evidence on stable post-EVAR status.
- Had a documented diagnosis of stage III or IV CKD and stable renal function.
- Was able to provide written informed consent.
- Was able and willing to comply with all study procedures as described in the protocol.
- Was pregnant, lactating, is possibly pregnant, or is actively trying to conceive during the study period.
- Was a patient for whom an endoleak or other clinically meaningful EVAR-related complication (as judged by the investigator) has already been discovered.
- Was undergoing surveillance following a Thoracic Endovascular Repair (TEVAR).
- Had a known or suspected history of immediate or delayed hypersensitivity to iodine or any iodinated contrast medium.
- Was using metformin (e.g., Glucophage®) that cannot be discontinued for the period of 24 hours prior to the Baseline Visit and for at least 48 hours after the imaging procedure.
- Had been exposed to any intravascular iodinated contrast medium in the 7 days prior to the Baseline Visit.
- Had congestive heart failure (New York Heart Association [NYHA] Class IV) or hepatic failure/liver cirrhosis.
- Had Stage V CKD.
- Had a pre-existing requirement for renal dialysis.
- Had undergone percutaneous transluminal renal angioplasty (PTRA) within 12 months before the index EVAR procedure or is scheduled to undergo PTRA during the study period.
- Had any clinically active, serious, life-threatening disease, medical, or significant psychiatric condition; has a life expectancy of less than 6 months; or is, in the Investigator's opinion, unsuitable for participation in the study for any reason.
- Had been enrolled in another clinical study within the 30 days prior to the Screening Visit or is planned to enroll in another clinical study within the duration of this study.
- Had been previously enrolled in this study.
- Was using i.v. vasopressor or inotropic medications.
- Had used nonsteroidal anti-inflammatory drugs (NSAIDs) or any nephrotoxic medication within 48 hours of the Baseline Visit or will do so within 72 hours after the CT procedure-with the exception of acetylsalicylic acid (Aspirin) at a dose of ≤100 mg daily (QD).
- Had been hospitalized within 30 days prior to Screening Visit for any reason other than practical purposes for management of tests or diagnostic assessments.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Saline: Non-Enhanced Computed Tomography (NECT) Placebos Participants received 1 intravenous injection of saline placebo (matched to Visipaque™ 320 mg I/ml injection) and underwent computed tomography (CT) examination and supplemental non-contrast duplex ultrasonography imaging examination. Visipaque™: Contrast-Enhanced Computed Tomography (CECT) Visipaque Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
- Primary Outcome Measures
Name Time Method Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria 48 hours post-baseline (Follow-up 1) 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.
- Secondary Outcome Measures
Name Time Method Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN) 48 hours post-baseline (Follow-up 1) Standard definition of CIN: Increase in SCr of 0.5 mg/dL or more in the 24 to 72 hours after the CT scan.
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria 48 hours post-baseline (Follow-up 1) 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.
All Cause Mortality and Morbidity From Baseline to Month 6 Mortality (all cause death) and morbidity i.e. critical events.
Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale Month 6 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).
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria 48 hours post-baseline (Follow-up 1) 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.
Trial Locations
- Locations (29)
Central Arkansas Veteran's Healthcare System
🇺🇸Little Rock, Arkansas, United States
UZ Leuven
🇧🇪Leuven, Belgium
: Aventiv Research Inc.
🇺🇸Mesa, Arizona, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
University Hospital
🇺🇸Birmingham, Alabama, 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
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Mount Sinai West
🇺🇸New York, New York, United States
The Duluth Clinic, Ltd.
🇺🇸Duluth, Minnesota, United States
University of North Carolina at Chapel Hill Clinical Translational Research Center
🇺🇸Chapel Hill, North Carolina, United States
Wake Forest Baptist Health
🇺🇸Winston-Salem, North Carolina, United States
CRCHUM- CHUM Research Center
🇨🇦Montreal, Canada
Oddzial Chirurgii Ogolnej i Naczyn, Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego
🇵🇱Poznan, Poland
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
St. Boniface General Hospital
🇨🇦Winnipeg, Canada
Hospital Universitario Puerta del Mar
🇪🇸Cadiz, Spain
Klinika Kardiochirurgii i Chirurgii Naczyniowej, Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Poland
St. George's Healthcare NHS Trust, St. George's Hospital
🇬🇧London, United Kingdom
Hospital Universitario Son Espases
🇪🇸Palma, Spain
Oddzial Chirurgii Naczyniowej i Ogolnej, Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu
🇵🇱Bytom, Poland
Klinika Chirurgii Naczyniowej i Angiologii, Samodzielny Publiczny Szpital Kliniczny nr 1
🇵🇱Lublin, Poland
Royal Stoke University Hospital, Radiology Department
🇬🇧Stoke on Trent, United Kingdom
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States