Investigation of Novel and Established Therapies in a Human Intravenous Lipopolysaccharide Model of Sepsis

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBelfast Health and Social Care Trust

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

  • Imatinib

    Drug

    Pre-treatment with 600mg Imatinib administered 1 hour prior to intravenous LPS.

  • Compound sodium lactate solution

    Drug

    Total 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

65 Participants
are divided into 4 treatment groups
Group A: Intravenous LPS onlyNo intervention 0 interventions
Group B: Intravenous LPS AND Intravenous Fluid Therapy*Experimental treatment 1 intervention
Group C: Intravenous LPS AND Imatinib TherapyExperimental treatment 1 intervention
Group D: Intravenous LPS AND Intravenous Fluid Therapy AND Imatinib TherapyExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Biomarkers of vascular and glycocalyx injury

Change in plasma biomarkers of vascular and glycocalyx injury including but not limited to - Hyaluronan

Time frame
Up to 8 hours following LPS administration

Secondary outcomes

1

Biomarkers of inflammation

Change in plasma biomarkers of inflammation including but not limited to - Interleukin-6

Time frame
Up to 8 hours following LPS administration
2

Venous Excess Ultrasound Score

Ultrasound measure of venous congestion

Time frame
Up to 8 hours following LPS administration
3

B-lines

Ultrasound measure of pulmonary oedema

Time frame
Up to 8 hours following LPS administration

Other outcomes

Locations

This trial has no 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: