Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: bacterial endotoxin challenge

• Registration Number: NCT01647997
• Lead Sponsor: University of Lausanne

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2004-03
• Study Completion: 2004-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-19
• Last Update Submitted: 2012-07-19
• Study First Posted: 2012-07-24
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study 1a	bacterial endotoxin challenge	whole body lactate production after bacterial endotoxin challenge
study 2a	bacterial endotoxin challenge	muscle lactate concentration after bacterial endotoxin challenge

Primary Outcome Measures

Name	Time	Method
Whole body lactate production	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	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

Secondary Outcome Measures

Name	Time	Method
whole body energy expenditure	single bacterial endotoxin administration; measurements over 6.5 hours following administration	open circuit indirect calorimetry (hood)
body temperature	single bacterial endotoxin administration; measurements over 6.5 hours following administration

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland