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临床试验/NCT01992237
NCT01992237Unknown不适用

Pilot Study of Measuring Energy Expenditure in ECMO Patients Under Consideration of Type of Ventilation and to Approximate Cardiac Output

Charite University, Berlin, Germany1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Energy expenditure in kcal

研究概览

简要总结

With the perception that lung protective ventilation with regard to low tidal volume ventilation and limiting airway pressures improves outcome in ARDS (acute respiratory distress syndrome) and that the development of new technical devices of extracorporeal lung assist systems with lower complication rates support establishment of lung protective ventilation strategies these systems are more and more frequently used. All critically ill patients with and without ECLA (extracorporeal lung assist)/ECMO (extracorporeal membrane oxygenation) treatment are on high risk for muscle wasting, leading to more comorbidity and higher mortality risk. Besides inflammation malnutrition is known as one of the main risk factors. Over and underfeeding should be prevented. However nutritional aspects of patients on extracorporeal lung assist are hardly investigated. Up to now changes in metabolic rates induced by ECLA/ECMO are poorly described. Factors like work of breathing, changes in cardiac output and septic state are influencing energy metabolism but until now there is no tool for measuring energy expenditure in clinical routine for patients on ECLA/ECMO. Indirect calorimetry is a simple device only for patients without ECLA/ECMO system. Oxygenation and CO2 (carbon dioxide) elimination by the lung assist system can be calculated but is not implemented to clinical routine. The combination of indirect calorimetry and calculation of lung assist function at the same time would give us the chance to adapt nutrition rates to energy expenditure. This may prevent muscle wasting and weakness. This pilot study will include 40 participating patients during 8 month investigating nutritional therapy adapted to energy expenditure calculated by O2 and CO2 turnover rates in patients on ECLA or ECMO systems. The investigators aim is to describe a calculation to set nutrition targets in ECMO patients. Second the investigators will describe level of nutritional needs under consideration of different mechanical ventilation states. Third O2 consumption and CO2 elimination will be used to estimate cardiac output.

研究设计

研究类型
Observational
观察模型
Case Only
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

  • critically ill patients with ALI
  • informed consent by the patients or legal proxy

排除标准

  • age < 18
  • no informed consent by the patients or legal proxy
  • pregnancy
  • infaust prognosis

结局指标

主要结局

Energy expenditure in kcal

时间窗: Once within first week after ECMO /ECLA was removed for 20 minutes

Measurement of energy expenditure with ECMO / ECLA use.

次要结局

  • Estimation of cardiac output in liter per minute(Calculated from the six measurements of the energy expenditure (as described above) during the ICU stay)
  • Energy expenditure in kcal(Once during ECMO / ECLA treatment and spontaneous breathing with supportive mechanical ventilation for 20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Steffen Weber-Carstens

PD Dr. med. Steffen Weber-Carstens

Charite University, Berlin, Germany

研究点 (1)

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