Prognostic Value of Exhaled Isoprene Levels for Morbidity and Functional Outcome in Cardiosurgical Patients - A Single Center Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery
研究概览
简要总结
The perioperative preservation of functionality and quality of life plays an increasingly important role in older physically limited and frail patients undergoing cardiac surgery. Hereby, impairments of the skeletal muscle system integrity often contributes to a reduced physical performance. Early identification of these high-risk patients could help to initiate appropriate preventive and therapeutic measures. Volatile organic compounds (VOC) represent a non-invasive and real-time measurable approach for recording physiological and pathophysiological processes. Isoprene (2-methyl-1,3-butadiene) is one of the most abundantly exhaled VOCs and has recently been shown to originate from skeletal muscle metabolism. However, the prognostic value of isoprene as a volatile biomarker for skeletal muscle integrity, physical performance and functional outcome in patients undergoing cardiac surgery has not been evaluated before.
详细描述
This is a single center prospective observational study evaluating exhaled isoprene as a perioperative volatile biomarker of skeletal muscle integrity, physical performance and functional outcome in cardiosurgical patients. All study participants will be assessed by comprehensive clinical examinations, laboratory testing, breath analysis and skeletal muscle ultrasound before, during as well as five and thirty days after surgery. Clinical assessments will be performed using established clinical scores and scales (e.g. the Short Physical Performance Battery and the Fried Frailty Index). Laboratory testing comprises a broad panel of blood-based biomarkers of skeletal muscle integrity and metabolism.
The investigators hypothesize that:
- perioperative exhaled isoprene levels correlate with postoperative measures of physical performance, functional outcome and morbidity
- perioperative exhaled isoprene levels differ between patients with and without physical frailty
- perioperative exhaled isoprene levels correlate with sonographic and laboratory parameters of skeletal muscle integrity
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 65 years
- •planned cardiac surgery
- •operation duration >60 min
排除标准
- •refusal of study participation
- •emergency / urgent surgery
- •acute myocardial infarction
- •acute or chronic infection
- •Pre-existing illness with permanent restriction of mobility
- •Pre-existing neuromuscular disease
- •current malignant disease
- •terminal renal insufficiency
- •severe liver cirrhosis
- •severe obstructive pulmonary disease
结局指标
主要结局
Short Physical Performance Battery
时间窗: day 5 after surgery
Assessment of patient's physical performance using the Short Physical Performance Battery (SPPB, Score, scales 0-12), whereby a higher SPPB corresponds to a better physical performance.
次要结局
- Muscle thickness(day 5 after surgery)
- Morbidity(day 30 after surgery)
- Isoprene concentration in patients with and without frailty(day 5 after surgery)
- Cumulated Ambulation Score(days 5 and 30 after surgery)
- Concentrations of blood-based biomarkers(day 5 after surgery)
- Medical Research Council Sum Score(day 5 after surgery)
研究者
Felix Klawitter, MD
Dr. med. Felix Klawitter, DESAIC
University of Rostock