Clinical Trial

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

Study acronym: INITIALISE
Not Yet Recruiting Phase 1/2
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Record status
This record was last updated October 4, 2024 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT06626984
Lead Sponsor Belfast Health and Social Care Trust
Collaborators: Medical Research Council, The Royal College of Anaesthetists
Conditions Sepsis, Fluid Overload, Endothelial Dysfunction, Microcirculation
Enrollment 65 participants
Start Date 2024-12-01
Primary Completion 2026-02-01 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2024-10-04