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
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
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Vaud
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Lausanne, Vaud, Schweiz, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: study 1a
whole body lactate production after bacterial endotoxin challenge
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iv administration of 2ng/kg bacterial endotoxin
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Inget ingripande: study 1b
basal whole body lactate production
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Experimentell: study 2a
muscle lactate concentration after bacterial endotoxin challenge
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iv administration of 2ng/kg bacterial endotoxin
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Inget ingripande: study 2b
basal muscle lactate concentrations
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Whole body lactate production
Tidsram: 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 |
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
|
skeletal muscle lactate concentration
Tidsram: 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
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single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
whole body energy expenditure
Tidsram: single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
open circuit indirect calorimetry (hood)
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
|
body temperature
Tidsram: single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: René Chiolero, MD, Centre Hospitalier Universitaire Vaudois
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Lsne-128/01
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