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

NCT06626984 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2024-10-04

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Fluid Overload
  • Endothelial Dysfunction
  • Microcirculation

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.

Sponsors & Collaborators

  • Medical Research Council

    collaborator OTHER_GOV

  • The Royal College of Anaesthetists

    collaborator OTHER

  • Belfast Health and Social Care Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-02-01
Completion
2026-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06626984 on ClinicalTrials.gov