NCT05906758

Ultra-Low Contrast Angiography in AKI

Randomized Controlled Trial of Ultra-Low Contrast Coronary Angiography During Acute Kidney Injury (AKI)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Tulane University · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the safety of ultra-low contrast coronary angiography in patients with pre-existing acute kidney injury.

Detailed description

The study is a non-inferiority open-label randomized controlled trial. Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial. Once indication for invasive coronary angiography is determined, patients will be randomized to immediate angiography or to delayed angiography after renal function stabilizes. Immediate angiography will be performed within 24 of enrollment. 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. Definitions: AKI is defined as an increase in serum creatinine by ≥50% from baseline within 7 days or an increase in serum creatinine by ≥0.3 mg/dl within 2 days. CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
PROCEDURE	Angiography	Coronary angiography with less than 20cc of contrast materials

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2023-06-18
• Last updated: 2025-09-23

Locations

2 sites across 1 country: United States