Ultra-Low Contrast Angiography in AKI
Part of paid clinical trials in New Orleans, Louisiana.
- Sponsor
- Tulane University
- Study ID
- NCT05906758
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Acute Kidney Injury
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- Angiography — PROCEDURECoronary angiography with less than 20cc of contrast materials
Study Details
The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.
Key Dates
- Start date
- Sep 5, 2025
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Immediate intervention armImmediate angiography will be performed within 24 hours of enrollment. Omnipaque contrast will be administered. Serum creatinine will be collected on enrollment, within 6 hours before coronary angiography, and at 24h, 48h and 1-week after the angiography, as expected in common practice. Pre- and post-hydration administration will be at the discretion of the treating physician. In case percutaneous coronary intervention is indicated it will be schedule for 7 days after angiography.
- Placebo Comparator: Delayed intervention armDelayed angiography will be performed after kidney function stabilizes.
Primary Outcome Measure
Change in incidence of Contrast Induced Nephropathy (CIN) [ Time Frame: Within 7 days ]
Central Contacts
- Zach Rozenbaum, MD504-988-5493
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Tulane University Medical Center | New Orleans | Louisiana | 70112 | Zach Rozenbaum, MD (PRINCIPAL_INVESTIGATOR) |
| University Medical Center | New Orleans | Louisiana | 70112 | Zach Rozenbaum, MD (PRINCIPAL_INVESTIGATOR) |
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