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

Validation of AKI-Sapere Model to Predict Patients at Risk for AKI After Cardiac Surgery: GUARD-AKI (GUiding Against Reserve Decline)

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • WakeMed Health and Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All subjects entered into this study will be patients at the participating institutions.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	within 7 days post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
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)	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	30 days post-surgery
Development of 30-day major adverse cardiac events (MACE30): a composite of myocardial infarction (MI), stroke, heart failure, and death	30 days post-surgery
Development of the combination of MAKE30 and MACE30 (major adverse reno-cardiovascular events [MARCE30])	30 days post-surgery
Development of 30-day persistent kidney impairment (eGFR change of ≥25% from baseline at the 30-day follow-up visit)	30 days post-surgery
Development of new onset atrial fibrilation	within 7 days post-surgery

Collaborators and Investigators

• Sponsor: Sapere Bio
• Collaborators: Johns Hopkins University; Hoag Memorial Hospital Presbyterian; WakeMed Health and Hospitals
• Investigators: Principal Investigator: Natalia Mitin, PhD, Sapere Bio

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): February 28, 2023

Study Registration Dates

• First Submitted: August 15, 2018
• First Submitted That Met QC Criteria: August 15, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: HSDX-1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No