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Phase IV Randomized Double-Blinded Placebo-Controlled Noninferiority Study of the Effect of Intravenous Low-Osmolality Iodinated Contrast Material On Renal Function in Postoperative Adults With Stage IIIb or Stage IV Chronic Kidney Disease
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.
Details
| Lead sponsor | University of Michigan |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 1 |
| Start date | 2015-07 |
| Completion | 2015-09 |
Conditions
- Acute Kidney Injury
Interventions
- Iopamidol 300 (Contrast)
- Placebo (Normal Saline)
Primary outcomes
- Participants With Stage II AKI (Acute Kidney Injury) — 48 hours
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.
Countries
United States