Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

University of Lausanne (UNIL)

Status: Completed

Conditions: Sepsis

Treatments: Other: bacterial endotoxin challenge

Study type: Interventional

Funder types: Other

Identifiers

NCT01647997

Lsne-128/01

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

study 1a

Experimental group

Description:

whole body lactate production after bacterial endotoxin challenge

Treatment:

Other: bacterial endotoxin challenge

study 1b

No Intervention group

Description:

basal whole body lactate production

study 2a

Experimental group

Description:

muscle lactate concentration after bacterial endotoxin challenge

Treatment:

Other: bacterial endotoxin challenge

study 2b

No Intervention group

Description:

basal muscle lactate concentrations