GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients

Sapere Bio370 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

370

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients (\>40 years) undergoing non-emergency (urgent or scheduled) cardiac surgery using cardiopulmonary bypass (CABG or combined CABG/valve). * Patients must be able to understand English and be willing to sign informed consent. Exclusion Criteria: * Emergency surgery * Off-pump coronary bypass grafting * Aortic aneurysm repair * Congenital heart disease repair * Heart transplant or left ventricular assist device patient * Severe heart failure (left ventricular ejection fraction \<25%) * Hemodynamic instability or requiring preoperative vasopressors or IABP * Pre-existing kidney disease (eGFR \<30 mL/min/1.73 m2) or renal transplantation. * Presence of major active infection (chronic or acute, eg, sepsis, HIV, pneumonia) * Chronic liver disease/cirrhosis * Participation in an additional trial at the time of surgery or anytime within 30d of surgery where intervention could potentially alter renal health (unless in the control arm)

Locations (3)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Johns Hopkins University

Baltimore, Maryland, United States

WakeMed Health and Hospitals

Raleigh, North Carolina, United States

Outcomes

Primary Outcomes

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)

Time frame: within 7 days post-surgery

Secondary Outcomes

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)

Time frame: 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)

Time frame: 30 days post-surgery

Development of new onset atrial fibrilation

Time frame: 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

Time frame: 30 days post-surgery

Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death

Time frame: 30 days post-surgery

Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30])

Time frame: 30 days post-surgery