RECRUITING

Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury

Description

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.

Study Overview

Study Details

Study overview

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.

Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury

Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury

Condition
Kidney Injury, Acute
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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%.
  • 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 highly effective contraception starting at screening and during study participation.
  • * Ability to take oral medication and be willing to adhere to the study intervention regimen.
  • * Ability to understand and willingness to agree to an informed consent
  • * Already fulfilling definition of acute kidney injury prior to contrast exposure by kidney disease improving global outcomes (KDIGO) criteria (absolute increase in creatinine from baseline of 0.3mg/dL or more OR relative increase in creatine of 50% or more from baseline).
  • * Primary indication for Percutaneous Coronary Intervention (PCI) including acute ST-segment elevation myocardial infarction
  • * End-stage renal disease actively on dialysis.
  • * Received any intravenous or intraarterial contrast within five days from planned contrast administration.
  • * Cardiac arrest within 14 days of planned contrast administration.
  • * Systolic blood pressure \< 100mmHg or diastolic blood pressure \<60mmHg OR currently receiving inotropes or vasopressors for hemodynamic support.
  • * History of hypersensitivity or known allergy to any of the components of the investigational product or placebo including sodium nitrate, inorganic nitrate, beet root juice, or lactose. This does not include lactose intolerance.
  • * Pregnancy or nursing female
  • * Participation in other investigational trials within the past 30 days prior to enrollment.
  • * Use of tadalafil within 48 hours, sildenafil or vardenafil within 24 hours, and avanafil within 12 hours of initiation of trial medication. If participant is on continuous dosing of tadalafil, sildenafil, vardenafil, or avanafil, they will be excluded from the trial. If participant is on intermittent dosing of tadalafil, sildenafil, vardenafil, or avanafil, patient agrees to withhold use of medication for duration of medication treatment extending 48 hours after the final dose.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Hitinder Gurm, MBBS, STUDY_CHAIR, University of Michigan

David Hamilton, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2026-07