Parallel-Group, Placebo-Controlled Randomized Study Investigating the Effect of Intravenous Iso-osmolar Iodinated Contrast Material Iodixanol (Visipaque™ Injection 320 mgI/mL) on Renal Function in Adults With Chronic Kidney Disease (CKD) Stage III or Stage IV Who Have Undergone Endovascular Aneurysm Repair (EVAR)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 29
- 主要终点
- Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
研究概览
简要总结
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.
详细描述
GEHC has decided not to provide this detail
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Visipaque™: Contrast-Enhanced Computed Tomography (CECT)
Participants received 1 intravenous injection of Visipaque™ 320 mg I/ml injection (100 mL iodixanol) and underwent computed tomography (CT) examination.
干预措施: Visipaque (Drug)
Saline: Non-Enhanced Computed Tomography (NECT)
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.
干预措施: Placebos (Drug)
结局指标
主要结局
Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=1 Per Acute Kidney Injury Network (AKIN) Serum Creatinine (SCr) Criteria
时间窗: 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.
次要结局
- Assessment of the Incidence of Acute Kidney Injury (AKI) by Contrast Induced Nephropathy (CIN)(48 hours post-baseline (Follow-up 1))
- Assessment of the Incidence of Acute Kidney Injury (AKI) Stage >=2 By Waikar Criteria(48 hours post-baseline (Follow-up 1))
- All Cause Mortality and Morbidity(From Baseline to Month 6)
- Blinded Independent Assessment of Image Quality/Diagnostic Confidence Using a 5-Point Scale(Month 6)
- 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))