Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT01647997
First received: July 17, 2012
Last updated: July 19, 2012
Last verified: July 2012

July 17, 2012
July 19, 2012
April 2002
March 2004   (final data collection date for primary outcome measure)
  • Whole body lactate production [ Time Frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration ] [ Designated as safety issue: No ]

    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 [ Time Frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration ] [ Designated as safety issue: No ]
    interstitial muscle measured by means of in vivo microdialysis ; calculation of muscle-blood lactate gradient
Same as current
Complete list of historical versions of study NCT01647997 on ClinicalTrials.gov Archive Site
  • whole body energy expenditure [ Time Frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration ] [ Designated as safety issue: No ]
    open circuit indirect calorimetry (hood)
  • body temperature [ Time Frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Lactate Metabolism After an Endotoxin Challenge in Healthy Humans
Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers

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

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Sepsis
Other: bacterial endotoxin challenge
iv administration of 2ng/kg bacterial endotoxin
  • Experimental: study 1a
    whole body lactate production after bacterial endotoxin challenge
    Intervention: Other: bacterial endotoxin challenge
  • No Intervention: study 1b
    basal whole body lactate production
  • Experimental: study 2a
    muscle lactate concentration after bacterial endotoxin challenge
    Intervention: Other: bacterial endotoxin challenge
  • No Intervention: study 2b
    basal muscle lactate concentrations
Michaeli B, Martinez A, Revelly JP, Cayeux MC, Chioléro 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2004
March 2004   (final data collection date for primary outcome measure)

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
Male
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01647997
Lsne-128/01
No
Luc Tappy, MD, University of Lausanne
University of Lausanne
Centre Hospitalier Universitaire Vaudois
Principal Investigator: René Chiolero, MD Centre Hospitalier Universitaire Vaudois
University of Lausanne
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP