LSALT Peptide for Prevention or Attenuation of Acute Kidney Injury (AKI) in Patients Undergoing On-Pump Cardiac Surgery
Trial Parameters
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Brief Summary
To evaluate the percentage of subjects with AKI within 7 days following on-pump cardiac surgery defined by the KDIGO (Kidney Disease: Improving Global Outcomes) criteria: 1. Increase in baseline (pre-surgery) serum creatinine (SCr) by ≥26.5 μmol/L (≥0.3 mg/dL) within 7 days; OR 2. Increase in baseline SCr to ≥1.5 times baseline, which is known or presumed to have occurred within the first 7 days following surgery; OR 3. Urine output \< 0.5 mL/kg/h for \>6 hours.
Eligibility Criteria
Inclusion Criteria: 1. Male and female ≥ 18 years of age. 2. Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to: * Coronary artery bypass graft (CABG) alone * CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair * Aortic valve replacement or repair alone, with or without aortic root repair * Mitral, tricuspid, or pulmonic valve replacement or repair alone * Simultaneous replacement of several cardiac valves. 3. Have the following AKI risk factors: * CKD Stage 3 (CKD-EPI eGFR ≥ 30 and \< 60 mL/min/1.73 m2) and ONE or more of the following additional risk factors OR * CKD Stage 2 (CKD-EPI eGFR ≥ 60 and \< 90 mL/min/1.73 m2) and ONE or more of the following additional risk factors: * Age ≥ 75 years; * Combined valve \& coronary artery surgery; * Left ventricular ejection fraction (LVEF) ≤ 35% by invasive or noninvasive techniques; * Urinary (TIMP-2 x IGFBP7) \> 0.3 * Diabetes me