Investigating the effects of intravenous fluids and imatinib in human volunteers with a sepsis-like state

Investigation of novel and established therapies in a human intravenous lipopolysaccharide model of sepsis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16409847

Enrollment

Registered

2024-04-02

Start date

2027-08-04

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Infections and Infestations

Interventions

Current interventions as of 18/09/2025: Study A (n=5): Healthy volunteers will receive IV Compound Sodium Lactate 30 mL/kg (two 15 mL/kg boluses at 999 mL/h, max 2.5 L) without LPS or Imatinib to as

Eligibility

Sex/Gender

All

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Healthy adult volunteers aged between 18 and 40 years of age 2. Informed consent to participate

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 18/09/2025: Biomarker based outcomes: Biomarkers of systemic inflammation including but not limited to differential white cell count, C- reactive protein, Il-6 and TNF-a Biomarkers of endothelial and vascular injury including but not limited to including but not limited to Hyaluronan, Heparan Sulphate and Angiopoietin-2 For Study A, blood sampling and lung ultrasound will be performed at baseline and four subsequent timepoints (T0–T4) aligned with the fluid boluses, but without LPS administration. For Study B & Study C blood sampling will occur at the following time points: • T0 (Baseline): Before any intervention. • T1: 1 h post-LPS. • T2: 3 h post-LPS • T3: 5 h post-LPS • T4: 7 h post-LPS _____ Previous primary outcome measures as of 01/10/2024: 1. Inflammation is assessed by measuring circulating levels of white blood cells, C- reactive protein, IL-6 and TNF-a at baseline, 1 hour, 3 hours, 5 hours and 7 hours post intravenous LPS administration 2. Vascular injury is assessed by measuring circulating levels of Hyaluronan, Heparan Sulphate and Angiopoietin-2 at baseline, 1 hour, 3 hours, 5 hours and 7 hours post intravenous LPS administration _____ Previous primary outcome measures: 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.	—

Measure

Time frame

Current primary outcome measure as of 18/09/2025: Biomarker based outcomes: Biomarkers of systemic inflammation including but not limited to differential white cell count, C- reactive protein, Il-6 and TNF-a Biomarkers of endothelial and vascular injury including but not limited to including but not limited to Hyaluronan, Heparan Sulphate and Angiopoietin-2 For Study A, blood sampling and lung ultrasound will be performed at baseline and four subsequent timepoints (T0–T4) aligned with the fluid boluses, but without LPS administration. For Study B & Study C blood sampling will occur at the following time points: • T0 (Baseline): Before any intervention. • T1: 1 h post-LPS. • T2: 3 h post-LPS • T3: 5 h post-LPS • T4: 7 h post-LPS _____ Previous primary outcome measures as of 01/10/2024: 1. Inflammation is assessed by measuring circulating levels of white blood cells, C- reactive protein, IL-6 and TNF-a at baseline, 1 hour, 3 hours, 5 hours and 7 hours post intravenous LPS administration 2. Vascular injury is assessed by measuring circulating levels of Hyaluronan, Heparan Sulphate and Angiopoietin-2 at baseline, 1 hour, 3 hours, 5 hours and 7 hours post intravenous LPS administration _____ Previous primary outcome measures: 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.

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Secondary

Measure	Time frame
Current secondary outcome measures as of 18/09/2025: Ultrasound based outcomes Pulmonary oedema, defined as B-line score For Study A, blood sampling and lung ultrasound will be performed at baseline and four subsequent timepoints (T0–T4) aligned with the fluid boluses, but without LPS administration. For Study B & Study C blood sampling will occur at the following time points: • T0 (Baseline): Before any intervention. • T1: 1 h post-LPS. • T2: 3 h post-LPS • T3: 5 h post-LPS • T4: 7 h post-LPS _____ Previous secondary outcome measures as of 01/10/2024: 1. Biological network alteration is assessed by measuring differential mRNA expression at baseline, 1 hour and 5 hours post intravenous LPS administration 2. Pulmonary oedema is assessed by measuring an ultrasound-based B-line score at baseline, 1 hour, 3 hours and 5 hours post intravenous LPS administration 3. Venous congestion is assessed by measuring an ultrasound-based Venous Excess Ultrasound (VExUS) Score at baseline, 1 hour, 3 hours and 5 hours post intravenous LPS administration _____ Previous secondary outcome measures: 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 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 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	—

Measure

Time frame

Current secondary outcome measures as of 18/09/2025: Ultrasound based outcomes Pulmonary oedema, defined as B-line score For Study A, blood sampling and lung ultrasound will be performed at baseline and four subsequent timepoints (T0–T4) aligned with the fluid boluses, but without LPS administration. For Study B & Study C blood sampling will occur at the following time points: • T0 (Baseline): Before any intervention. • T1: 1 h post-LPS. • T2: 3 h post-LPS • T3: 5 h post-LPS • T4: 7 h post-LPS _____ Previous secondary outcome measures as of 01/10/2024: 1. Biological network alteration is assessed by measuring differential mRNA expression at baseline, 1 hour and 5 hours post intravenous LPS administration 2. Pulmonary oedema is assessed by measuring an ultrasound-based B-line score at baseline, 1 hour, 3 hours and 5 hours post intravenous LPS administration 3. Venous congestion is assessed by measuring an ultrasound-based Venous Excess Ultrasound (VExUS) Score at baseline, 1 hour, 3 hours and 5 hours post intravenous LPS administration _____ Previous secondary outcome measures: 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 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 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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026