Ultra-Low Contrast Angiography in AKI

Acute Kidney Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05906758
• Other study ID #: 2023-874
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2024
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: Tulane University
• Contact: Zach Rozenbaum, MD
• Phone: 504-988-5493
• Email: zrozenbaum[@]tulane.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Hospitalized patients who have AKI at admission or who develop AKI during admission and require invasive coronary angiography will be included in the trial.

Exclusion Criteria:

• Stabilized renal function manifested by unchanged or downtrending serum creatinine during a 24-hour period prior to enrollment.

• Contraindication for invasive coronary angiography other than AKI.

• Percutaneous coronary intervention is indicated and cannot be postponed by 7 days.

• Need for renal replacement therapy before coronary angiography or planned renal replacement therapy after coronary angiography (if premeditated before coronary angiography).

• Administration of intravascular contrast media during 7 days prior to the coronary angiography or within 6 days after coronary angiography.

• Pregnant patients, prisoners, cognitively impaired subjects, age below 18 years, unable or unwilling to provide informed consent.

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Procedure:
• Angiography
Coronary angiography with less than 20cc of contrast materials

Locations

Country	Name	City	State
United States	Tulane University Medical Center	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in incidence of Contrast Induced Nephropathy (CIN)	CIN is defined as an increase in serum creatinine by 0.5mg/dl or a relative rise of 25% from the baseline value. The investigators will measure the incidence of CIN by the increase in serum creatinine to see if the incidence will be the same in both arms whether the patient received the immediate angiography or if it was delayed until kidney function has been stabilized.	Within 7 days
Secondary	Incidence of earlier occurrence of CIN	The investigators will measure serum creatinine at 24, 48 hours and at 1 week to measure if the occurrence of CIN will happen earlier in 1 arm than the other	Within 7 days
Secondary	Incidence of renal replacement therapy at up to 7 days post-angiography	The investigators will measure the incidence of renal replacement therapy by monitoring if the patient will undergo dialysis within 7 days post angiography	Within 7 days