Lactate Metabolism After an Endotoxin Challenge in Healthy Humans
Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers
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
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Vaud
-
Lausanne、Vaud、瑞士、CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- gender male
- body mass index (BMI) < 25 kg/m2
- absence of known disease
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：study 1a
whole body lactate production after bacterial endotoxin challenge
|
iv administration of 2ng/kg bacterial endotoxin
|
|
无干预：study 1b
basal whole body lactate production
|
|
|
实验性的：study 2a
muscle lactate concentration after bacterial endotoxin challenge
|
iv administration of 2ng/kg bacterial endotoxin
|
|
无干预：study 2b
basal muscle lactate concentrations
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Whole body lactate production
大体时间：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 |
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
|
skeletal muscle lactate concentration
大体时间：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
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
whole body energy expenditure
大体时间：single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
open circuit indirect calorimetry (hood)
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
|
body temperature
大体时间：single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
合作者和调查者
调查人员
- 首席研究员：René Chiolero, MD、Centre Hospitalier Universitaire Vaudois
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Lsne-128/01
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