SepsisNCT01647997
Lactate Metabolism After an Endotoxin Challenge in Healthy Humans
A study testing bacterial endotoxin challenge in people with Sepsis, run by University of Lausanne at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- What is being tested?
- bacterial endotoxin challenge
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2002to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- gender male
- body mass index (BMI) < 25 kg/m2
- absence of known disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: 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.
Read more
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
- Conditions
- Sepsis
- Being tested
- bacterial endotoxin challenge
- Keywords
- bacterial lipopolysaccharides, hyperlactatemia, muscle lactate
- Medical subject headings
- Sepsis, Hyperlactatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bacterial endotoxin challengeOther
iv administration of 2ng/kg bacterial endotoxin
| Study group | Role | What they receive |
|---|---|---|
| study 1a | Experimental | whole body lactate production after bacterial endotoxin challenge Receives: Other: bacterial endotoxin challenge |
| study 1b | No intervention | basal whole body lactate production |
| study 2a | Experimental | muscle lactate concentration after bacterial endotoxin challenge Receives: Other: bacterial endotoxin challenge |
| study 2b | No intervention | basal muscle lactate concentrations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body lactate production
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
Measured: single bacterial endotoxin administration; measurements over 6.5 hours following administration
skeletal muscle lactate concentration
interstitial muscle measured by means of in vivo microdialysis ; calculation of muscle-blood lactate gradient
Measured: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Secondary outcomes (2)
whole body energy expenditure
open circuit indirect calorimetry (hood)
Measured: single bacterial endotoxin administration; measurements over 6.5 hours following administration
body temperature
Measured: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startApr 2002
- Primary completionMar 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- René Chiolero, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647997
- Sponsor's protocol ID
- Lsne-128/01
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22839504
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Acute Administration of Bacterial Endotoxin on Whole Body and Regional Lactate Metabolism in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01647997
- Acronym / sponsor ID
- Lsne-128/01
- Conditions
- Sepsis
- Keywords
- bacterial lipopolysaccharides, hyperlactatemia, muscle lactate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Apr 2002
- Primary completion
- Mar 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| study 1a | Experimental | Other: bacterial endotoxin challengewhole body lactate production after bacterial endotoxin challenge |
| study 1b | No intervention | –basal whole body lactate production |
| study 2a | Experimental | Other: bacterial endotoxin challengemuscle lactate concentration after bacterial endotoxin challenge |
| study 2b | No intervention | –basal muscle lactate concentrations |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- gender male
- body mass index (BMI) < 25 kg/m2
- absence of known disease
Key exclusion criteria (7 listed)
- any known pathology
- abnormal cardio-pulmonary and hemodynamic status
- electrocardiographic alterations
- history of allergy
- current medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bacterial endotoxin challengeiv administration of 2ng/kg bacterial endotoxin | Other | study 1a, study 2a |
Primary outcome
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
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
2 secondary outcomes
whole body energy expenditure
Time frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
body temperature
Time frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2012.
- Derived from this study: PubMed 22839504Michaeli 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.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
René Chiolero, MD principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bacterial endotoxin challenge in people with Sepsis, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole body lactate production (time frame: single bacterial endotoxin administration; measurements over 6.5 hours following administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2012.