Body Composition Monitoring for Determination of the Fluid Status in Volunteers Undergoing Intravenous Fluid Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload.
研究概览
简要总结
This volunteer study tests a recently developed whole-body bioimpedance spectroscopy device called Body Composition Monitor (BCM) which measures the body composition (i.e. the water content of the body).
Specifically, the investigators will evaluate the use of BCM for correct detection of intravenous administered crystalloids in the volunteers´ fluid compartments. Furthermore we will test the change over time of the volunteers´ volume status after an intravenous fluid therapy.
详细描述
Technically assisted assessment of volume status may be useful to direct fluid administration.
As a prerequisite the investigators will test a recently developed whole-body bioimpedance spectroscopy device to determine fluid status in volunteers after an intravenous fluid therapy.
The correlation of infused fluid and change of the fluid status measured with Body Composition Monitor (BCM, Fresenius Medical Care, Germany) is still unknown.
Using a three-compartment physiologic tissue model, BCM determine total body fluid volume (TBV), extracellular volume (ECV), intracellular volume (ICV) and fluid overload (FO) as surplus or deficit of 'normal' extracellular volume. The BCM device measures resistance and reactance at 50 discrete frequencies covering the frequency spectrum from 5 to 1000 kHz through the entire patient via 4 electrodes placed on the wrist and ankle.
Fifteen volunteers will be enrolled in a randomized, blinded cross over study. After randomisation into one of two treatments the volunteer will receive either an iv isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour or no fluid therapy. At the second study day the volunteer will obtain the opposite treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged between 18 and 50 years
- •BMI < 30 kg/m2
- •Written informed consent given by volunteers after being provided with detailed information about the nature, risks, and scope of the clinical study
排除标准
- •Implanted pacemaker or defibrillator
- •Limb amputation identified by physical examination
- •Known allergy or hypersensitivity to Elo-Mel
- •Abnormalities in Blood pressure (Hypotension with a systolic BP < 90 mmHg and hypertension with a systolic BP > 160 mmHg) after 5 min resting
- •Cardiac insufficiency (NYHA≥ 2)
- •Renal insufficiency (GFR ≤ 60 ml/min)
研究组 & 干预措施
Fluid Therapy
Intravenous isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour.
Body Composition Monitoring every 10 minutes for 6hours.
干预措施: Elo-mel® (Fresenius Kabi Austria) (Drug)
Fluid Therapy
Intravenous isotonic fluid therapy of Elo-mel® (Fresenius Kabi Austria) at a rate of 0,50ml/kg/min for one hour.
Body Composition Monitoring every 10 minutes for 6hours.
干预措施: Body Composition Monitoring (Device)
Zero Therapy
Body Composition Monitoring every 10 minutes for 6hours. No intravenous fluid therapy
干预措施: Body Composition Monitoring (Device)
结局指标
主要结局
Body composition, especially Extracellular Volume, Intracellular Volume, Total Body Fluid Volume and Fluid Overload.
时间窗: 6 hours
The primary outcome parameter is the correct detection of the iv fluid therapy by a corresponding increase in the parameters ExtraCellular Volume (ECV), Total Body Fluid Volume (TBV) and Fluid Overload (FO).
次要结局
- Change over time of the body fluid compartments after iv fluid therapy(6 hours)
研究者
Barbara Kabon
MD
Medical University of Vienna