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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03635606
• Other study ID #: HSDX-1801
• Status: Completed
• Start date: February 24, 2020
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Sapere Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 370
• Est. completion date: February 28, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California
United States	WakeMed Health and Hospitals	Raleigh	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Sapere Bio	Hoag Memorial Hospital Presbyterian, Johns Hopkins University, WakeMed Health and Hospitals

Country where clinical trial is conducted

United States, 

Outcome

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