About this trial
Sepsis is a common and life-threatening condition caused by a dysregulated host immune response to infection. Given the prominent role of endothelial breakdown and dysfunction in sepsis, therefore, there is an urgent need to establish strategies to protect the endothelium and preserve microcirculatory function.
This study is a randomised clinical study investigating intravenous fluid therapy and oral imatinib therapy in healthy human volunteers exposed to intravenous lipopolysaccharide (LPS).
The objective of the study is to investigate the biological effects of fluid and imatinib therapy on LPS-induced microcirculatory dysfunction.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adult volunteers aged between 18 and 40 years of age
Informed consent to participate
Disqualifiers
Current participation in a clinical trial
Pregnant or breastfeeding
Current history of smoking
Alcohol intake > 21 units per week
Trial design
Factorial
Treatments tested in this trial
Imatinib
DrugPre-treatment with 600mg Imatinib administered 1 hour prior to intravenous LPS.
Compound sodium lactate solution
DrugTotal of 30 ml/kg administered 90 minutes following intravenous LPS. 30mls/kg (maximum volume of 2500mls) administered in two divided doses (15mls/kg) intravenously. Each bolus will be administered at a fixed rate of 999mls/hr.
Treatment groups
Trial outcomes
Primary outcomes
Biomarkers of vascular and glycocalyx injury
Change in plasma biomarkers of vascular and glycocalyx injury including but not limited to - Hyaluronan
Secondary outcomes
Biomarkers of inflammation
Change in plasma biomarkers of inflammation including but not limited to - Interleukin-6
Venous Excess Ultrasound Score
Ultrasound measure of venous congestion
B-lines
Ultrasound measure of pulmonary oedema
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Belfast Health and Social Care Trust
Lead sponsor
Medical Research Council
Collaborator
The Royal College of Anaesthetists
Collaborator
This trial is not recruiting at the moment. You can still explore other options: