Clinical trial NCT03635606: GUARD-AKI: Validation of AKI-Sapere in Cardiac Surgery Patients
Official title: Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Sapere Bio
Sponsor class: INDUSTRY
Collaborators: name: WakeMed Health and Hospitals
name: Johns Hopkins University
name: Hoag Memorial Hospital Presbyterian
First posted: 2018-08-17
Enrollment: 370
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects entered into this study will be patients at the participating institutions.

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: 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)
timeFrame: within 7 days post-surgery
Secondary outcomes:
measure: 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)
timeFrame: within 7 days post-surgery
measure: Development of 30-day persistent kidney impairment (eGFR change of ≥25% from baseline at the 30-day follow-up visit)
timeFrame: 30 days post-surgery
measure: Development of new onset atrial fibrilation
timeFrame: within 7 days post-surgery
measure: 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
timeFrame: 30 days post-surgery
measure: Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death
timeFrame: 30 days post-surgery
measure: Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30])
timeFrame: 30 days post-surgery
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Raleigh
country: United States
facility: WakeMed Health and Hospitals
state: North Carolina
Study officials:
affiliation: Sapere Bio
name: Natalia Mitin, PhD
role: PRINCIPAL_INVESTIGATOR
References: