Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
University of Michigan
Summary
This pilot study is designed to test the logistics and recruitment of a trial testing the benefit of sodium nitrate in the prevention of contrast-associated kidney injury in a group of patients at high-risk.
Description
The timing of the follow-up blood test was changed from 48 hours (± 12 hours) to 72 hours (± 36 hours) after contrast exposure. This change allows participants more flexibility to complete their lab work at a convenient outpatient location without requiring a return visit within a narrow time window. The new timing still falls within the period when kidney function changes from contrast exposure would be expected to appear, so the study's ability to detect these changes is preserved and safety monitoring remains consistent.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Planned coronary angiogram or contrast-enhanced CT scan. * High-risk for contrast-associated acute kidney injury (AKI) with creatine/Glomerular filtration rate (GFR) within 90 days as defined as: 1. Undergoing coronary angiogram with GFR \<45 mL/min/1.73m2 OR 2. Undergoing coronary angiogram with GFR \<60 mL/min/1.73m2 and concurrent risk of AKI as defined by Hamilton et al. BMC2 risk prediction model ≥ 7%. OR 3. Undergoing contrast-enhanced CT scan with GFR\<45 mL/min/1.73m2 * If subject is a woman of child-bearing potential, subject agrees to the use of hi…
Interventions
- DrugSodium Nitrate
The study drug is sodium nitrate capsule at a dose of 12mmol of nitrate. This medication will be given orally 1-8 hours before the planned contrast administration and then once per day for a total of four doses.
- DrugPlacebo
The placebo control medication will be a capsule filled with lactose that will be taken in the same manner and schedule as the sodium nitrate capsule
Location
- University of MichiganAnn Arbor, Michigan