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

NCT03635606 | Completed

• 1 other identifier: HSDX-1801
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 3

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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 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

• 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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Sapere Bio: lead
• WakeMed Health and Hospitals: collaborator
• Johns Hopkins University: collaborator
• Hoag Memorial Hospital Presbyterian: collaborator

Study Sites (3)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

WakeMed Health and Hospitals

Raleigh, North Carolina, 27610, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, plasma, urine

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Natalia Mitin, PhD

  Sapere Bio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: February 24, 2020
• Primary Completion: September 1, 2022
• Study Completion: February 28, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)