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临床试验/NCT02332070
NCT02332070已完成不适用

Timing of Coronary Angiography and Multivariate Risk for Cardiac Surgery Associated Acute Kidney Injury and Major Adverse Renal and Cardiac Events (MARCE)

Baylor Research Institute1 个研究点 分布在 1 个国家目标入组 965 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
965
试验地点
1
主要终点
Contrast-induced acute kidney injury

研究概览

简要总结

  1. To examine two main predictor variables independently and then jointly in stratified and multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and inpatient mortality, and the composite, as well as the outcomes of 30 day rehospitalization or death, and finally for the days out of hospital and alive adjusted to person-year of time

  2. Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)

  3. Thakar Acute Renal Failure (ARF) score (1 to 17)

  4. To examine the interrelationships between time in days between angiogram and surgery and the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality

详细描述

Background: Despite advances in cardiac surgical techniques, modern anesthesia, and adjunctive medical therapies, cardiac-surgery associated acute kidney injury (CSA-AKI) remains a frequent and important complication. With advancing age and more severe comorbidities present in patients undergoing cardiac surgery, multivariate scores (e.g. Thakar Acute Renal Failure [ARF] score) would anticipate future higher rates of CSA-AKI that resolve, lead to progressive chronic kidney disease (CKD), require renal replacement therapy (RRT), and are associated major adverse cardiac events with early and later mortality. Mehta and colleagues in a study of 2441 cases suggested that CSA-AKI was associated with the time between the diagnostic coronary angiogram and the subsequent surgery. This suggested that superimposed risk of contrast-induced AKI (CI-AKI) followed by cardiac surgery was a serial insult to the kidneys producing the clinical syndrome of CSA-AKI. However, Andersen and coworkers, in a study of 285 consecutive patients concluded that cardiac surgery within 1-3 days of coronary angiography was safe and not associated with CSA-AKI. Attempts at evaluating CSA-AKI risk prediction models have been limited by small sample sizes. For example, Kiers et el attempted to evaluate 8 CSA-AKI risk models in 1388 patients and found several scores could not be computed due to lack of information and those that could have unstable point estimates for C-statistics and other measures. As a result, CSA-AKI risk scores and attempts to improve quality of care have not been applied in a widespread manner to cardiac surgical cases. Thus we propose to evaluate these key concepts in a large dataset which captures important clinical events such as CI-AKI and type of contrast used followed by CSA-AKI and associated major adverse renal and cardiac events (MARCE) including the need for RRT, myocardial infarction, stroke, heart failure, hospitalizations (cardiac or renal) and death. We aim to derive a practical approach in determining the optimal waiting period from the time of angiography to cardiac surgery according to risk for CSA-AKI in subjects who have received iso-osmolar contrast media (IOCM) with preoperative angiography, as that agent has been shown to have the lowest risk of CI-AKI.

Specific Aims:

  1. To examine two main predictor variables independently and then jointly in stratified and multivariate analyses for the outcomes of CSA-AKI, MARCE, need for RRT, and inpatient mortality, and the composite, as well as the outcomes of 30 day rehospitalization or death, and finally for the days out of hospital and alive adjusted to person-year of time

  2. Days from coronary angiogram performed with IOCM to cardiac surgery (1, 2, 3, etc)

  3. Thakar Acute Renal Failure (ARF) score (1 to 17)

  4. To examine the interrelationships between time in days between angiogram and surgery and the ARF Score with the Society of Thoracic Surgery (STS) Risk score for mortality

Methods

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Cardiac surgery with or without cardiac valve surgery
  • At least one baseline and postoperative serum creatinine (mg/dl)

排除标准

  • Use of contrast agent other than IOCM with the preoperative angiogram
  • Preoperative use of ventricular assist devices and intraaortic balloon counterpulsation.
  • Operations where there is implantation of mechanical assist devices or cardiac transplant

结局指标

主要结局

Contrast-induced acute kidney injury

时间窗: 7 days

KDIGO definition

Cardiac surgery associated acute kidney injury

时间窗: 7 days

KDIGO definition

Major adverse renal and cardiac events

时间窗: 30 days

Composite of need for renal replacement therapy, myocardial infarction, stroke, heart failure, hospitalizations for cardiac reasons, hospitalization for renal reasons, and death

次要结局

  • Stroke(30 days)
  • Heart failure(30 days)
  • Renal replacement therapy(30 days)
  • Myocardial Infarction(30 days)
  • Hospitalization for renal reasons(30 days)
  • Hospitalization for cardiac reasons(30 days)
  • Death(30 days)
  • All-cause hospitalization(30 days)
  • Days out of the hospital and alive(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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