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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Sodium Nitrate

    Drug

    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.

  • Placebo

    Drug

    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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Sodium NitrateExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percent 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
2

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
3

Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure

Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure

Time frame
Approximately 34 days
4

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
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