Clinical trial NCT02496234: The Use of Aging Biomarkers to Predict Adverse Outcomes After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Bypass Graft Surgery
Acute kidney injury
Renal failure
Biomarker
Lead sponsor: Sapere Bio
Sponsor class: INDUSTRY
Collaborators: name: Duke University
First posted: 2015-07-14
Enrollment: 186
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects entered into this study will be patients of the Duke University Health System.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 48-72 hours
Secondary outcomes:
measure: Number of Participants who suffered postoperative stroke
timeFrame: 30 days
measure: Number of Participants who suffered cognitive decline
timeFrame: 30 days
measure: Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)
timeFrame: 30 days
measure: Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.
timeFrame: 30 days
measure: Number of Participants with cardiac arrest
timeFrame: 30 days
measure: Number of Participants with perioperative myocardial infarction
timeFrame: 30 days
measure: Number of Participants with perioperative ventricular dysfunction.
timeFrame: 30 days
measure: Number of Participants with postoperative deep sternal wound infection
timeFrame: 30 days
measure: Number of Participants with postoperative thoracotomy infection
timeFrame: 30 days
measure: Number of Participants with postoperative sepsis.
timeFrame: 30 days
measure: Number of Participants in need for renal replacement therapy
timeFrame: 30 days
measure: Number of Participants who progressed to end stage renal disease.
timeFrame: 30 days
measure: Death
timeFrame: 1 year
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Mihai V Podgoreanu, MD, FASE
role: PRINCIPAL_INVESTIGATOR
References: