Clinical trial NCT01647997: Lactate Metabolism After an Endotoxin Challenge in Healthy Humans
Official title: Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: bacterial lipopolysaccharides
hyperlactatemia
muscle lactate
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Vaudois
First posted: 2012-07-24
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: Whole body lactate production
timeFrame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
measure: skeletal muscle lactate concentration
timeFrame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Secondary outcomes:
measure: whole body energy expenditure
timeFrame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
measure: body temperature
timeFrame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois
name: René Chiolero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michaeli B, Martinez A, Revelly JP, Cayeux MC, Chiolero RL, Tappy L, Berger MM. Effects of endotoxin on lactate metabolism in humans. Crit Care. 2012 Jul 27;16(4):R139. doi: 10.1186/cc11444.