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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
|
| Sodium Nitrate | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Approximately 34 days |
| 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 | 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. | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion 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:
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%.
OR
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allison Schley | Contact | 734-232-9051 | schleya@umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Hitinder Gurm, MBBS | University of Michigan | Study Chair |
| David Hamilton, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C031618 | sodium nitrate |
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|
| 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 |
|
| Approximately 34 days |
| 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) | MACE is a composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke within 30 days of planned contrast administration | 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 | Approximately 34 days |
| Number of participants with non-fatal myocardial infarction within 30 days of planned contrast administration | 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) | 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 | 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. | Approximately 34 days |
| Number of participants with new onset hypotension | Approximately 34 days |
| Number of adverse events within 30 days of planned contrast administration | Approximately 34 days |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |