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| Name | Class |
|---|---|
| WakeMed Health and Hospitals | OTHER |
| Johns Hopkins University | OTHER |
| Hoag Memorial Hospital Presbyterian | OTHER |
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Cardiac surgery associated acute kidney injury (CSA-AKI) has been recognized as the second most common cause of hospital acquired AKI. The development of CSA-AKI is independently associated with an increased risk of in-hospital death. There are currently no biomarkers that could identify patients at higher risk for AKI and current risk predictor scores that are based on clinical and demographic information are inadequate. Therefore, a diagnostic test for predicting AKI risk in this clinical context would assist clinicians to optimize surgical strategy and postoperative care to prevent CSA-AKI occurrence and improve patient outcomes.
The primary purpose of this study is to validate a panel of biomarkers identified in the discovery study (referred to as AKI-Sapere prognostic) to identify patients at risk for all stages of CSA-AKI.
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| Measure | Description | Time Frame |
|---|---|---|
| Development of stage 1 or higher postoperative AKI as defined by the KDIGO classification (stage 1 = sCr value of ≥0.3 mg/dL in the first 48h or a relative increase of ≥50% in peak sCr from baseline within 7 days post-surgery) | within 7 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Development of moderate to severe AKI (sCr increase of ≥100% within 7 days post surgery or a sCr increase of ≥100% from baseline within 7 days and urine output <0.5 mL/kg/h for >12h) | within 7 days post-surgery | |
| Development of 30-day persistent kidney impairment (eGFR change of ≥25% from baseline at the 30-day follow-up visit) |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects entered into this study will be patients at the participating institutions.
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| Name | Affiliation | Role |
|---|---|---|
| Natalia Mitin, PhD | Sapere Bio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Newport Beach | California | 92663 | United States | ||
| Johns Hopkins University |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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whole blood, plasma, urine
| 30 days post-surgery |
| Development of new onset atrial fibrilation | within 7 days post-surgery |
| Development of 30-day major adverse kidney events (MAKE30): a composite of persistently impaired renal function (sCr increase of ≥0.5 mg/dL from baseline [pre-surgery]), new dialysis, and death | 30 days post-surgery |
| Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death | 30 days post-surgery |
| Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30]) | 30 days post-surgery |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| WakeMed Health and Hospitals | Raleigh | North Carolina | 27610 | United States |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |