Double-Blind Placebo-Controlled CIN Trial
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Acute Kidney Injury
In brief
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.
Key facts
- Study ID
- NCT02467075
- Run by
- University of Michigan
- People needed
- 1
- Starts
- 2015-07-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-06-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Michigan Hospital Department of Radiology — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.