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Lactate Metabolism After an Endotoxin Challenge in Healthy Humans

NCT ID: NCT01647997

Last Updated: 2012-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2004-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Sepsis

Keywords

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bacterial lipopolysaccharides hyperlactatemia muscle lactate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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study 1a

whole body lactate production after bacterial endotoxin challenge

Group Type EXPERIMENTAL

bacterial endotoxin challenge

Intervention Type OTHER

iv administration of 2ng/kg bacterial endotoxin

study 1b

basal whole body lactate production

Group Type NO_INTERVENTION

No interventions assigned to this group

study 2a

muscle lactate concentration after bacterial endotoxin challenge

Group Type EXPERIMENTAL

bacterial endotoxin challenge

Intervention Type OTHER

iv administration of 2ng/kg bacterial endotoxin

study 2b

basal muscle lactate concentrations

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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bacterial endotoxin challenge

iv administration of 2ng/kg bacterial endotoxin

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role collaborator

University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

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Luc Tappy, MD

Professor of Physiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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René Chiolero, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois

Locations

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Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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Michaeli B, Martinez A, Revelly JP, Cayeux MC, Chiolero 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.

Reference Type DERIVED
PMID: 22839504 (View on PubMed)

Other Identifiers

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Lsne-128/01

Identifier Type: -

Identifier Source: org_study_id