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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02496234
• Other study ID #: HSDX-1503
• Status: Completed
• Phase: N/A
• First received: July 8, 2015
• Last updated: November 22, 2016
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2016
• Source: HealthSpan Dx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• 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 measure the association between baseline expression of senescence markers in blood using SenesceTest and the occurrence of CSA-AKI post surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
HealthSpan Dx	Duke University

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 AKIN classification (stage 1- = 0.5 mg/dL absolute or = 50% relative rise in peak SCr over the baseline)		48-72 hours	No
Secondary	Number of Participants who suffered postoperative stroke		30 days	No
Secondary	Number of Participants who suffered cognitive decline		30 days	No
Secondary	Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)		30 days	No
Secondary	Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.		30 days	No
Secondary	Number of Participants with cardiac arrest		30 days	No
Secondary	Number of Participants with perioperative myocardial infarction		30 days	No
Secondary	Number of Participants with perioperative ventricular dysfunction.		30 days	No
Secondary	Number of Participants with postoperative deep sternal wound infection		30 days	No
Secondary	Number of Participants with postoperative thoracotomy infection		30 days	No
Secondary	Number of Participants with postoperative sepsis.		30 days	No
Secondary	Number of Participants in need for renal replacement therapy		30 days	No
Secondary	Number of Participants who progressed to end stage renal disease.		30 days	No
Secondary	Death		1 year	No