The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02496234
• Lead Sponsor: Sapere Bio

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 measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-08
• Study First Submitted QC: 2015-07-09
• Study First Posted: 2015-07-14
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 186

Inclusion Criteria

Patients must fulfill all criteria to be eligible for this study:

• Adult patients (>18 yo) undergoing non-emergency cardiac surgery using cardiopulmonary bypass (CABG, combined CABG/valve, or valve surgery).

Exclusion Criteria

Patients who fulfill any of the following criteria will be excluded:

• Emergency surgery.
• Off-pump coronary bypass grafting.
• Aortic aneurysm repair.
• Congenital heart disease repair.
• Heart transplant or LVAD patient.
• Severe heart failure (LVEF<25%).
• Hemodynamic instability or requiring preoperative vasopressors or IABP.
• Pre-existing end-stage kidney disease (eGFR< 15 mL/min/1.73 m2) or renal transplantation.
• Presence of major active infection (chronic or acute, e.g. sepsis, HIV, pneumonia).
• Chronic liver disease /cirrhosis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of stage 1 or higher postoperative AKI as defined by the AKIN classification (stage 1- ≥ 0.5 mg/dL absolute or ≥ 50% relative rise in peak SCr over the baseline)	48-72 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants who suffered cognitive decline	30 days
Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)	30 days
Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.	30 days
Number of Participants with cardiac arrest	30 days
Number of Participants who suffered postoperative stroke	30 days
Number of Participants with perioperative myocardial infarction	30 days
Number of Participants with perioperative ventricular dysfunction.	30 days
Number of Participants who progressed to end stage renal disease.	30 days
Number of Participants with postoperative deep sternal wound infection	30 days
Number of Participants with postoperative thoracotomy infection	30 days
Number of Participants with postoperative sepsis.	30 days
Number of Participants in need for renal replacement therapy	30 days
Death	1 year

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States