An interventional study of LPS infusion in Sepsis, Inflammation and LPS, sponsored by Barmherzige Brüder Linz. Completed at 1 site in Austria. Open to male participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by Barmherzige Brüder Linz · Not applicable, Interventional, and Basic science
It has been recognized lately that sepsis and inflammation has an important impact on lipid metabolism and that the extent of hypocholesterolemia may even be a marker of severity of illness. However, the interplay between inflammation and the marked changes in lipid metabolism remain to be sufficiently understood. Importantly, the exact kinetics of lipid parameters in inflammatory conditions are yet to be explored. This study aims to investigate the interaction between inflammation and lipid metabolism using the human endotoxin model (LPS infusion) in ten healthy volunteers in a single blinded randomized placebo controlled cross-over design.
Sepsis is a severe clinical syndrome with still limited means of therapy and often poor prognosis. It has been recognized lately that sepsis and inflammation has an important impact on lipid metabolism and that the extent of hypocholesterolemia may even be a marker of severity of illness.
This study aims to investigate the interaction between inflammation and lipid metabolism and the possible role of various markers of lipid metabolism including apolipoprotein B, apoA1 and lipoprotein(A) using the human endotoxin model in ten healthy volunteers. In this model, volunteers are infused intravenously with bacterial lipopolysaccharide (LPS, 2 ng/kg over 5 minutes) to simulate human sepsis. Immediately after the infusion of LPS, proinflammatory cytokines and other mediators are elevated just as they are in common sepsis. This widely used model thus represents a reliable method for evaluating conditions during inflammation.
In this study, LPS will be administered to ten healthy male volunteers aged 18-40 years and plasma levels of lipid parameters including those described above will subsequently be measured repeatedly to evaluate the influence of LPS on lipid metabolism and detailed kinetics of lipid parameters.
This project is planned as a prospective, single blinded randomized, placebo controlled cross-over study. Participants must be free of disease history and previous anaphylactic events, must not be on any medication and will be screened for medical disorders including renal, hepatic and cardiovascular conditions, thrombophilia and infections in an initial medical examination. Each participant will be studied on two different study days with a washout period of at least 14 days, on which either LPS (National Reference Bacterial Endotoxin, lot EC-6, prepared from Escherichia coli 0113, USPC, Inc. Rockville, MD) and saline or saline alone as a placebo will be administered. LPS will be infused in a dosage of 2 ng/kg over a period of 5 minutes. Participants will be studied after an overnight fast and after 24 hours without smoking and without consumption of caffeine-containing beverages in order to ensure standard baseline conditions. During the study, subjects will rest in a supine position. Infusion and sampling will be done using two separate intravenous catheters.
Blood samples will be centrifuged, transferred into chilled tubes and placed on ice. Plasma will be frozen at -80°C until it will be assayed. Plasma and urine sodium, potassium, creatinine and glucose will be measured via routine laboratory techniques.
A case record form will be completed for each volunteer and data will subsequently be handled in an anonymous manner. Data will be analysed using repeated measures ANOVA.
In summary, this study aims to evaluate the interactions between sepsis and lipid metabolism using the human endotoxin model. Such knowledge could improve the understanding of the pathophysiology in sepsis and may lead to the development of novel therapeutic strategies. Insights on possible interactions between inflammation and lipid metabolism could also enlighten pathophysiological pathways in metabolic syndrome and type 2 diabetes mellitus causing chronic low-grade inflammation with potential impact on various medical fields.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's enrollment of 10 is below the median of 102 across 1,165 interventional studies indexed under Sepsis.
Browse Sepsis studies →Barmherzige Brüder Linz is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
infusion of LPS 2 ng/kg over 5 minutes
Biological: LPS infusion
NaCl
Biological: LPS infusion
infusion of LPS 2 ng/kg over 5 minutes
lipid kinetics
levels of lipid parameters including LDL, HDL, lipoprotein(a), apolipoprotein A1 and apoB will be measured at multiple timepoints (t0, t15, t30, t60, t120, t180, t360, 24h and 48h) in order to evaluate the detaile kinetics of lipid parameters in inflammatory condidtions
Time frame: 48 hours
Plan to share: Undecided
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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