Inorganic Nitrate (NaNO3) Prevention of Contrast-Associated Acute Kidney Injury
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo
Dispensing, and Labeling: The University of Michigan Research Pharmacy will compound sodium nitrate and placebo capsules. Placebo capsules will be compounded by filling a matching capsule with lactose.
干预措施: Placebo (Drug)
Sodium Nitrate
Dispensing, and Labeling: The University of Michigan Research Pharmacy will compound sodium nitrate and placebo capsules. Sodium nitrate powder will be measure and used for the active capsules with adding lactose as a filler.
干预措施: Sodium Nitrate (Drug)
结局指标
主要结局
Percent of participants with 48-hour basic metabolic panel collected between 36-108 hours of contrast exposure
时间窗: Approximately 34 days
Success is defined as greater than 80% of patients having appropriately collected 48-hour basic metabolic panel collected 36-108 hours of contrast exposure
Percent of participants recruited to the trial for undergoing coronary angiogram
时间窗: Approximately 34 days
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
Percent of participants receiving the first dose of blinded study drug within 1-8 hours prior to contrast exposure
时间窗: Approximately 34 days
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.
Percent of participants completing full course of 4 doses of blinded study drug
时间窗: Approximately 34 days
Success is defined as greater than 80% of patients completing the full course of 4 doses of blinded study drug
Percent of participants who had completion of clinical outcome monitoring at 30-day follow-up interview
时间窗: Approximately 34 days
Success is defined as greater than 80% of patients completing full clinical outcome monitoring at 30-day follow-up interview.
Percent of participants recruited to the trial for undergoing a contrast-enhanced CT scan
时间窗: Approximately 34 days
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.
次要结局
- Number of participants with cardiovascular death within 30 days of planned contrast administration as defined by cessation of life deemed secondary to cardiovascular cause(Approximately 34 days)
- Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration(Approximately 34 days)
- Number of adverse events within 30 days of planned contrast administration(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(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(Approximately 34 days)
- Number of participants with major adverse cardiovascular events (MACE)(Approximately 34 days)
- Number of participants with non-fatal stroke within 30 days of planned contrast administration(Approximately 34 days)
- Number of participants with major adverse kidney events (MAKE)(Approximately 34 days)
- Number of participants with persistent renal dysfunction at 30 days of planned contrast administration(Approximately 34 days)
- Number of participants with new onset hypotension(Approximately 34 days)
- Number of participants who develop of Contrast-Associated Acute Kidney Injury (CA-AKI)(Approximately 34 days)
研究者
Hitinder Gurm
Professor of Cardiovascular Medicine, Professor of Internal Medicine, and Chief Medical Officer, Medical School
University of Michigan