This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease. Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria. Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours before and after the CT..
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
1
Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
University of Michigan Hospital Department of Radiology
Ann Arbor, Michigan, United States
Participants With Stage II AKI (Acute Kidney Injury)
Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.
Time frame: 48 hours
Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition
Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity
Time frame: 48-72 hours
Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)
Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.
Time frame: 30 days
Hospital Length of Stay
Subject's hospital length of stay in days
Time frame: Duration of hospital stay (assessed from date of randomization up to 30 days)
30-day Readmission
Number of times a subject is readmitted within 30 days of study recruitment
Time frame: 30 days
Mortality Rate - 30 Day
Number of subjects who died within 30 days of entry into the study.
Time frame: 30 days
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