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

Launched by BELFAST HEALTH AND SOCIAL CARE TRUST · Oct 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at new and existing treatments to help improve blood flow and protect blood vessels during a serious condition called sepsis, which happens when the body has a severe reaction to an infection. The researchers will give healthy volunteers a substance called lipopolysaccharide (LPS) to mimic the effects of sepsis and then test how well intravenous fluids and a medication called imatinib work to support blood vessel function.

To be eligible for this study, volunteers need to be healthy adults between 18 and 40 years old and must agree to participate. Those currently taking certain medications, pregnant or breastfeeding, or with specific health issues won’t be able to join. Participants can expect to receive careful monitoring during the study, and their health will be checked before and during their participation. This trial is important because it aims to find effective treatments that could help people suffering from sepsis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy adult volunteers aged between 18 and 40 years of age
• • 2. Informed consent to participate
• Exclusion Criteria:
• • 1. Current participation in a clinical trial
• • 2. Pregnant or breastfeeding
• • 3. Current history of smoking
• • 4. Alcohol intake \> 21 units per week
• • 5. Regular intake of any relevant prescription or over-the-counter medication. Any regular medication use will be reviewed on a case-by-case basis as to (a) risk and (b) potential confounding effect.
• • 6. Oxygen saturation \<95% breathing room air
• • 7. Abnormal findings on history, examination or laboratory tests suggestive of underlying illness (in the opinion of the clinician undertaking screening)
• • 8. History of recurrent vaso-vagal episodes
• • 9. Allergy to Imatinib
• • 10. Positive or equivocal hepatitis B or C serology result