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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
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.
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
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGPercent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure
Success is defined as greater than 80% of patients receiving the first dose of blind study drug within 1-8 hours prior to contrast exposure.
Time frame: Approximately 34 days
Percent of participants completing full course of 4 doses of blinded study drug
Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug
Time frame: Approximately 34 days
Percent of participants with 48-hour basic metabolic panel collected between 36-60 hours of contrast exposure
Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-60 hours of contrast exposure
Time frame: Approximately 34 days
Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interview
Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.
Time frame: Approximately 34 days
Percent of participants recruited to the trial for undergoing coronary angiogram
Success is defined as four or more patients being recruited into the study prior to coronary angiogram each month of the study averaged over the study period
Time frame: Approximately 34 days
Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan
Success is defined as four or more patients being recruited into the study prior to contrast-enhanced CT scan each month of the study averaged over the study period.
Time frame: Approximately 34 days
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Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)
As defined by creatinine measurement at 48 hours after contrast administration meeting Kidney Disease Improving Global Outcomes (KDIGO) criteria
Time frame: Approximately 34 days
Number of participants who had initiation of renal replacement therapy within 30 days of planned contrast administration for patients that did not have active need for dialysis prior to study enrollment
Time frame: Approximately 34 days
Number of participants with all-cause mortality within 30 days of planned contrast administration as defined by cessation of life due to any cause
Time frame: Approximately 34 days
Number of participants with major adverse cardiovascular events (MACE)
MACE is a composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with cardiovascular death within 30 days of planned contrast administration as defined by cessation of life deemed secondary to cardiovascular cause
Time frame: Approximately 34 days
Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with non-fatal stroke within 30 days of planned contrast administration
Time frame: Approximately 34 days
Number of participants with major adverse kidney events (MAKE)
MAKE is a composite outcome of death, new renal replacement therapy, or persistent renal dysfunction within 30 days of planned contrast administration. Persistent renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days
Time frame: Approximately 34 days
Number of participants with persistent renal dysfunction at 30 days of planned contrast administration
Renal dysfunction is defined as creatinine value greater than or equal to 200% of baseline value at 30 days.
Time frame: Approximately 34 days
Number of participants with new onset hypotension
Time frame: Approximately 34 days
Number of adverse events within 30 days of planned contrast administration
Time frame: Approximately 34 days