Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
ConditionKidney Injury, Acute
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
Qualifiers
Planned coronary angiogram or contrast-enhanced CT scan.
Undergoing coronary angiogram with GFR <45 mL/min/1.73m2 OR
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%.
Undergoing contrast-enhanced CT scan with GFR<45 mL/min/1.73m2
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Sodium Nitrate
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov