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
Panoramica dello studio
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Vaud
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Lausanne, Vaud, Svizzera, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: study 1a
whole body lactate production after bacterial endotoxin challenge
|
iv administration of 2ng/kg bacterial endotoxin
|
|
Nessun intervento: study 1b
basal whole body lactate production
|
|
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Sperimentale: study 2a
muscle lactate concentration after bacterial endotoxin challenge
|
iv administration of 2ng/kg bacterial endotoxin
|
|
Nessun intervento: study 2b
basal muscle lactate concentrations
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Whole body lactate production
Lasso di tempo: 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
Lasso di tempo: 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
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
whole body energy expenditure
Lasso di tempo: 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
Lasso di tempo: single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
single bacterial endotoxin administration; measurements over 6.5 hours following administration
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: René Chiolero, MD, Centre Hospitalier Universitaire Vaudois
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Lsne-128/01
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .