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

NCT ID: NCT02496234

Last Updated: 2016-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-07-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Keywords

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Coronary Artery Bypass Graft Surgery Acute kidney injury Renal failure Biomarker

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

Sapere Bio

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mihai V Podgoreanu, MD, FASE

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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HSDX-1503

Identifier Type: -

Identifier Source: org_study_id