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临床试验/NCT02496234
NCT02496234已完成不适用

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

Sapere Bio1 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
1
主要终点
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)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

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)

时间窗: 48-72 hours

次要结局

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

研究者

发起方
Sapere Bio
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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