Ultra-Low Contrast Angiography in AKI

Purpose

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

Condition

  • Acute Kidney Injury

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Immediate intervention arm
Immediate 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.
  • Procedure: Angiography
    Coronary angiography with less than 20cc of contrast materials
Placebo Comparator
Delayed intervention arm
Delayed angiography will be performed after kidney function stabilizes.
  • Procedure: Angiography
    Coronary angiography with less than 20cc of contrast materials

Recruiting Locations

Tulane University Medical Center
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Zach Rozenbaum, MD
504-988-5493
zrozenbaum@tulane.edu

University Medical Center
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Zach Rozenbaum, MD
504-988-5493
zrozenbaum@tulane.edu

More Details

Status
Recruiting
Sponsor
Tulane University

Study Contact

Zach Rozenbaum, MD
504-988-5493
zrozenbaum@tulane.edu

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.