跳至主要内容
临床试验/NCT03169608
NCT03169608Unknown不适用

Predicting Post-surgery Complications in Patients Undergoing Coronary Artery Bypass Graft Through the Assessment of Perioperative Cardiovascular Control Indices

IRCCS Policlinico S. Donato1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年4月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Atrial Fibrillation

研究概览

简要总结

Characterization of the perioperative autonomic nervous system state, cardiovascular and cerebrovascular control and microcirculation in order to predict postoperative atrial fibrillation and acute kidney injury in patients undergoing coronary artery bypass graft surgery

详细描述

Atrial fibrillation (AF) and acute kidney injury (AKI) are common postoperative complications in patients undergoing coronary artery bypass graft (CABG) surgery. AKI increases postoperative mortality and AF prolongs the hospital stay.

Autonomic dysfunction, baroreflex impairment and an inadequate microvascular perfusion may play a relevant role in triggering AF and AKI.

The perioperative characterization of the autonomic nervous system (ANS) and of the microcirculation might improve risk stratification and help in the prevention and early treatment of AF and AKI in CABG surgery.

The study aims are: i) to collect a number of perioperative indices describing the state of the ANS and of the microcirculation; ii) to assess the correlation among the different indices and their association with AF and AKI; iii) to develop a predictive model of postoperative outcomes (AF and AKI) accounting for perioperative autonomic indices and microcirculatory variables.

Population: 200 adults subjects scheduled for CABG surgery, with or without additional intervention Methods: perioperative (in the operating room) acquisition of ECG, arterial blood pressure, cerebral blood flow velocity as derived from transcranial doppler technique, microcirculation parameters as derived from sidestream dark field images Statistics: receiver operating characteristic (ROC) curve analysis with adequate cut-off values

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18
  • sinus rhythm
  • absence of pathologies affecting autonomic nervous system (e.g. diabetes with neuropathy)
  • informed consent signed
  • elective or urgent surgery

排除标准

  • age under 18
  • absence of sinus rhythm
  • pathologies affecting autonomic nervous system
  • emergency surgery (to be operated immediately)

结局指标

主要结局

Atrial Fibrillation

时间窗: from the admission to the ICU to the hospital discharge, with an average of 8 days

any atrial fibrillation event recorded during the postoperative period, as derived from ECG monitoring

Acute Kidney Injury

时间窗: 48 hours from surgery

50% increase of serum creatinine with respect to baseline or absolute increase \> 0.3 mg/ml

次要结局

未报告次要终点

研究者

发起方
IRCCS Policlinico S. Donato
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Ranucci

Director of Cardiothoracic Anesthesia and ICU Dept

IRCCS Policlinico S. Donato

研究点 (1)

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