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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male and female ≥ 18 years of age.
✓. Scheduled for a non-emergent coronary and/or valve surgery procedure requiring on-pump cardiopulmonary bypass including but not limited to:
✓. Have the following AKI risk factors:
✓. Sexually active women of child-bearing potential (WCBP) must be using a medically acceptable method of birth control throughout the study and for at least 1 day following the end of study and have a negative urine pregnancy test at the Screening visit. A WCBP is defined as a female who is biologically capable of becoming pregnant. A medically acceptable method of birth control includes intrauterine devices in place for at least 3 months, surgical sterilization, or the implant. In patients who are not sexually active, abstinence is an acceptable form of birth control and urine will be tested per protocol. Women who are of nonchild-bearing potential, i.e., post-menopause, must have this condition captured in their medical history. Pregnant women and nursing mothers are excluded from this study.
✓. Patient or Legally Authorized Representative (LAR) is available and willing to give written informed consent, after being properly informed of the nature and risks of the study and prior to engaging in any study-related procedures.
Exclusion criteria
✕. The presence of AKI (KDIGO criteria) at the time of randomization
✕. Off-pump cardiac surgery
✕. Surgery to be performed under conditions of circulatory arrest or hypothermia with rectal temperature \< 28°C (82.4° F)
✕. Severe chronic kidney disease: CKD-eGFR \< 30 mL/min/1.73 m2) OR requiring dialysis
What they're measuring
1
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
✕. Imminent or recent surgery for aortic dissection
✕. Surgery to correct a major congenital heart defect (e.g., Tetralogy of Fallot, transposition of the great vessels, single ventricle, or Ebstein's anomaly. Bicuspid aortic valve is not considered a congenital heart defect)
✕. Known history of active cancer which may interfere with interpretation of the results of this study
✕. Known or suspected sepsis at time of screening