Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Whole body lactate production
研究概览
简要总结
Sepsis is characterized by hyperlactatemia, the severity of which is proportionate with sepsis severity. The pathophysiological mechanisms (increased lactate production vs decreased lactate utilization; tissues involved in sepsis-induced lactate production) remain largely unknown.
In this study, the investigators will assess whole body and regional metabolism in healthy young male subjects on two occasions, once after administration of an intravenous bacterial endotoxin challenge, and once without intervention.
In one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge
- Energy expenditure and net substrate oxidation rates (indirect calorimetry)
- Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)
- Glucose kinetics (measured with 6,6 d2 glucose)
- Hemodynamic parameters and body temperature
- Blood clinical chemistry In one group of subjects, whole body lactate metabolism will be measured over 10 hours after the endotoxin challenge
- Energy expenditure and net substrate oxidation rates (indirect calorimetry)
- Lactate kinetics (measured by means of a continuous, exogenous sodium lactate infusion)
- Glucose kinetics (measured with 6,6 d2 glucose)
- Hemodynamic parameters and body temperature
- Blood clinical chemistry
In a second group of subjects, regional muscle lactate metabolism will be measured over 10 hours after the endotoxin challenge by means of muscle microdialysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •gender male
- •body mass index (BMI) < 25 kg/m2
- •absence of known disease
排除标准
- •any known pathology
- •abnormal cardio-pulmonary and hemodynamic status
- •electrocardiographic alterations
- •history of allergy
- •current medications
- •drug abuse
- •consumption of more than 20g/day alcohol
结局指标
主要结局
Whole body lactate production
时间窗: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Whole body lactate clearance will be measured by measuring the increase in blood lactate at steady state during a conrtinuous exogenous sodium lactate infusion. Lactate production will be calculated as the product of lactate clearance times per-infusion blood lactate concentration
skeletal muscle lactate concentration
时间窗: single bacterial endotoxin administration; measurements over 6.5 hours following administration
interstitial muscle measured by means of in vivo microdialysis ; calculation of muscle-blood lactate gradient
次要结局
- whole body energy expenditure(single bacterial endotoxin administration; measurements over 6.5 hours following administration)
- body temperature(single bacterial endotoxin administration; measurements over 6.5 hours following administration)
研究者
Luc Tappy, MD
Professor of Physiology
University of Lausanne