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NOT YET RECRUITING
NCT06626984
PHASE1/PHASE2

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

Sponsor: Belfast Health and Social Care Trust

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2024-12-01

Completion Date

2026-07-01

Last Updated

2024-10-04

Healthy Volunteers

Yes

Interventions

DRUG

Imatinib

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

DRUG

Compound sodium lactate solution

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.