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NCT Number: NCT01647997

Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

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

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Key information

Conditions

Sepsis Hyperlactatemia Infections Inflammation Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, CH-1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bacterial endotoxin challenge

Other

iv administration of 2ng/kg bacterial endotoxin

Primary outcomes

  1. Whole body lactate production

    Time frame: 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

  2. skeletal muscle lactate concentration

    Time frame: 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 outcomes

  1. whole body energy expenditure

    Time frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration

    open circuit indirect calorimetry (hood)

  2. body temperature

    Time frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jul 24, 2012
Registry last updated
Jul 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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