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

November 22, 2016 updated by: Sapere Bio

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

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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)
Time Frame: 48-72 hours
48-72 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sapere Bio

Collaborators

Duke University

Investigators

  • Principal Investigator: Mihai V Podgoreanu, MD, FASE, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSDX-1503

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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