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OpenTrials
Completed

NCT Number: NCT02496234

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.

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Key information

Conditions

Coronary Artery Disease Acute Kidney Injury Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Kidney Diseases Male Urogenital Diseases Myocardial Ischemia Renal Insufficiency Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants who suffered postoperative stroke

    Time frame: 30 days

  2. Number of Participants who suffered cognitive decline

    Time frame: 30 days

  3. Number of Participants requiring prolonged mechanical ventilation (for longer than 24h)

    Time frame: 30 days

  4. Number of Participants with : cardiac arrest, perioperative myocardial infarction and perioperative ventricular dysfunction.

    Time frame: 30 days

  5. Number of Participants with cardiac arrest

    Time frame: 30 days

  6. Number of Participants with perioperative myocardial infarction

    Time frame: 30 days

  7. Number of Participants with perioperative ventricular dysfunction.

    Time frame: 30 days

  8. Number of Participants with postoperative deep sternal wound infection

    Time frame: 30 days

  9. Number of Participants with postoperative thoracotomy infection

    Time frame: 30 days

  10. Number of Participants with postoperative sepsis.

    Time frame: 30 days

  11. Number of Participants in need for renal replacement therapy

    Time frame: 30 days

  12. Number of Participants who progressed to end stage renal disease.

    Time frame: 30 days

  13. Death

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sapere Bio

Industry

Collaborators

  • Duke University

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Nov 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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