IntraRenal HEmoDynamics to IntegraTE CA-AKI Risk and Monitor NephroprotectiIoN by ImpElla Support.

Exclusion Criteria11

• Severe chronic kidney disease with eGFR ≤ 20 ml/min or on dialysis
• Patients with AKI within the last seven days prior screening or incipient AKI (in cases, where AKI cannot be ruled out as a cause for elevated serum creatinine, a rise or fall above 30% of a second serum creatinine measurement obtained within 12 to 24 hours is regarded indicative of AKI).
• STEMI ≤24 hours from the onset of ischemic symptoms or at any time if mechanical complications of transmural infarction are present (e.g., VSD, papillary muscle rupture, etc.)
• Cardiogenic shock (SBP \<80 mmHg for ≥30 mins and not responsive to intravenous fluids or hemodynamic deterioration for any duration requiring pressors or mechanical circulatory support, including IABP)
• Cardiorespiratory arrest related to the current admission unless subject is extubated for \>24 hours with full neurologic recovery and hemodynamically stable.
• Platelet count \<75,000 cells/mm3, bleeding diathesis or active bleeding, coagulopathy or unwilling to receive blood transfusions.
• Pregnant or child-bearing potential unless negative pregnancy test within 1 week
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device that has not reached its primary endpoint
• Any medical or psychiatric condition such as dementia, alcoholism or substance abuse which may preclude informed consent or interfere with any of the study procedures, including follow-up visits
• Any non-cardiac condition with life expectancy \<1 years (e.g., cirrhosis, cancer not in remission, etc.)
• Subject belongs to a vulnerable population (defined as individuals with mental disability, persons in nursing homes, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent; vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces and persons kept in detention)