Investigating the effects of intravenous fluids and imatinib in human volunteers with a sepsis-like state
Not Applicable
- Conditions
- SepsisInfections and Infestations
- Registration Number
- ISRCTN16409847
- Lead Sponsor
- Belfast Health and Social Care Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 65
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. Intake of any prescription and over-the-counter medication (except paracetamol, hormonal contraceptives and hormonal replacement therapy) within 7 days prior to the first dose of IMP
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. Known history of allergy to imatinib
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Microvascular flow index (MFI) measured using a CytoCam sublingual microscope at baseline, 90 minutes post-LPS, 2 hours post-LPS, 3 hours post-LPS, 4 hours post-LPS and 8 hours post-LPS. <br><br>
- Secondary Outcome Measures
Name Time Method 1. Perfused vessel density measured using a CytoCam sublingual microscope at baseline, 90 minutes post-LPS, 2 hours post-LPS, 3 hours post-LPS, 4 hours post-LPS and 8 hours post-LPS<br>2. Pulmonary oedema (B line score) measured using an ultrasound device at baseline, 2 hours post-LPS, 3 hours post-LPS and 4 hours post-LPS<br>3. Systemic venous congestion (VExUS score) measured using an ultrasound device at baseline, 2 hours post-LPS, 3 hours post-LPS and 4 hours post-LPS<br>