Double-Blind Placebo-Controlled CIN Trial

This double-blinded placebo-controlled non-inferiority study will examine the incidence and
significance of contrast-induced acute kidney injury following intravenous iodinated
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 pre and three hours post-CT.

Inclusion Criteria:

- Inpatients scheduled for CT scan of abdomen and/or pelvis

- Have had surgery in the last 4 weeks

- Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each
other, with most recent within 5 days of CT)

- Suspected infection or fluid collection in abdomen and/or pelvis

Exclusion Criteria:

- Pregnant

- Severe Allergy (anaphylaxis) to contrast

- Dialysis in last 7 days

- Received intravascular iodinated contrast in last 48 hours

- CT of abdomen and pelvis in last 7 days shows no fluid collection

- Prisoners

- CT ordered for an indication that necessitates (eg, CT angiogram) or contraindicates
(eg, renal stone CT) intravascular contrast