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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease

• Study Type: Observational
• Enrollment (Actual): 186

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 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 of the Duke University Health System.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Death	1 year
Number of Participants who suffered postoperative stroke	30 days
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 with perioperative myocardial infarction	30 days
Number of Participants with perioperative ventricular dysfunction.	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
Number of Participants who progressed to end stage renal disease.	30 days

Collaborators and Investigators

• Sponsor: Sapere Bio
• Collaborators: Duke University
• Investigators: Principal Investigator: Mihai V Podgoreanu, MD, FASE, Duke University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 8, 2015
• First Submitted That Met QC Criteria: July 9, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Biomarker; Acute kidney injury; Renal failure; Coronary Artery Bypass Graft Surgery
• 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-1503