Double-Blind Placebo-Controlled CIN Trial

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Radiological Society of North America

Criteria

Inclusion Criteria:

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

• 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 requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast