Sepsis Clinical Trial
Official title:
Possible Links Between Inflammation and Lipid Metabolism
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05095324 -
The Biomarker Prediction Model of Septic Risk in Infected Patients
|
||
| Completed |
NCT02714595 -
Study of Cefiderocol (S-649266) or Best Available Therapy for the Treatment of Severe Infections Caused by Carbapenem-resistant Gram-negative Pathogens
|
Phase 3 | |
| Completed |
NCT03644030 -
Phase Angle, Lean Body Mass Index and Tissue Edema and Immediate Outcome of Cardiac Surgery Patients
|
||
| Completed |
NCT02867267 -
The Efficacy and Safety of Ta1 for Sepsis
|
Phase 3 | |
| Completed |
NCT04804306 -
Sepsis Post Market Clinical Utility Simple Endpoint Study - HUMC
|
||
| Terminated |
NCT04117568 -
The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
|
||
| Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
| Completed |
NCT04332861 -
Evaluation of Infection in Obstructing Urolithiasis
|
||
| Completed |
NCT04227652 -
Control of Fever in Septic Patients
|
N/A | |
| Enrolling by invitation |
NCT05052203 -
Researching the Effects of Sepsis on Quality Of Life, Vitality, Epigenome and Gene Expression During RecoverY From Sepsis
|
||
| Terminated |
NCT03335124 -
The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
|
Phase 4 | |
| Recruiting |
NCT04005001 -
Machine Learning Sepsis Alert Notification Using Clinical Data
|
Phase 2 | |
| Completed |
NCT03258684 -
Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Sepsis and Septic Shock
|
N/A | |
| Recruiting |
NCT05217836 -
Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
|
||
| Completed |
NCT05018546 -
Safety and Efficacy of Different Irrigation System in Retrograde Intrarenal Surgery
|
N/A | |
| Completed |
NCT03295825 -
Heparin Binding Protein in Early Sepsis Diagnosis
|
N/A | |
| Not yet recruiting |
NCT06045130 -
PUFAs in Preterm Infants
|
||
| Not yet recruiting |
NCT05361135 -
18-fluorodeoxyglucose Positron Emission Tomography/Computed Tomography in S. Aureus Bacteraemia
|
N/A | |
| Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
| Not yet recruiting |
NCT04516395 -
Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae
|
N/A |