Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

Sepsis Clinical Trial

Official title:

Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647997
• Other study ID #: Lsne-128/01
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: July 19, 2012
• Start date: April 2002
• Est. completion date: December 2004

Study information

• Verified date: July 2012
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Sepsis

Intervention

Other:
• bacterial endotoxin challenge
iv administration of 2ng/kg bacterial endotoxin

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whole body lactate production	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	No
Primary	skeletal muscle lactate concentration	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	No
Secondary	whole body energy expenditure	open circuit indirect calorimetry (hood)	single bacterial endotoxin administration; measurements over 6.5 hours following administration	No
Secondary	body temperature		single bacterial endotoxin administration; measurements over 6.5 hours following administration	No