[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564269":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":12,"centralContacts":38,"locations":12,"responsibleParty":47,"collaborators":49,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":12,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":79,"overallStatus":81,"whyStopped":12,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":12},{"fullName":5,"class":6},"Belfast Health and Social Care Trust","OTHER",[8,13,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Intravenous LPS only","NO_INTERVENTION","LPS dose 2ng\u002Fkg.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intravenous LPS AND Intravenous Fluid Therapy*","EXPERIMENTAL","\\*The first 5 participants recruited to this study will receive intravenous fluid therapy only. This will allow us to directly elucidate the effects of intravenous fluid therapy on markers of vascular injury, markers of systemic inflammation, microcirculatory function and venous congestion in healthy volunteers.\n\nLPS dose 2ng\u002Fkg. Intravenous fluid 30ml\u002Fkg in total (maximum volume of 2500mls). Administered in two divided doses (15mls\u002Fkg) intravenously. Each bolus will be administered at a fixed rate of 999mls\u002Fhr. The administration is to commence 90 minutes following intravenous LPS.",[18],"Drug: Compound sodium lactate solution",{"label":20,"type":15,"description":21,"interventionNames":22},"Intravenous LPS AND Imatinib Therapy","LPS dose 2ng\u002Fkg. Imatinib 600mg 1 hour prior to LPS administration.",[23],"Drug: Imatinib",{"label":25,"type":15,"description":26,"interventionNames":27},"Intravenous LPS AND Intravenous Fluid Therapy AND Imatinib Therapy","LPS dose 2ng\u002Fkg. Intravenous fluid 30ml\u002Fkg in total (maximum volume of 2500mls). Administered in two divided doses (15mls\u002Fkg) intravenously. Each bolus will be administered at a fixed rate of 999mls\u002Fhr. The administration is to commence 90 minutes following intravenous LPS.\n\nImatinib 600mg 1 hour prior to LPS administration.",[23,18],[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":12},"DRUG","Imatinib","Pre-treatment with 600mg Imatinib administered 1 hour prior to intravenous LPS.",[20,25],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":12},"Compound sodium lactate solution","Total of 30 ml\u002Fkg administered 90 minutes following intravenous LPS. 30mls\u002Fkg (maximum volume of 2500mls) administered in two divided doses (15mls\u002Fkg) intravenously. Each bolus will be administered at a fixed rate of 999mls\u002Fhr.",[25,14],[39,44],{"name":40,"role":41,"phone":42,"phoneExt":12,"email":43},"Jon Silversides","CONTACT","+44 (0) 28 9097 6378","j.silversides@qub.ac.uk",{"name":45,"role":41,"phone":42,"phoneExt":12,"email":46},"Ross McMullan","rmcmullan07@qub.ac.uk",{"type":48,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[50,53],{"name":51,"class":52},"Medical Research Council","OTHER_GOV",{"name":54,"class":6},"The Royal College of Anaesthetists","100564269","phase-1-investigation-of-novel-and-established-therapies-in-a-human-intravenous-lipopolysaccharide-model-of-sepsis-100564269",false,"NCT06626984","Investigation of Novel and Established Therapies in a Human Intravenous Lipopolysaccharide Model of Sepsis","INITIALISE","Inclusion Criteria:\n\n1. Healthy adult volunteers aged between 18 and 40 years of age\n2. Informed consent to participate\n\nExclusion Criteria:\n\n1. Current participation in a clinical trial\n2. Pregnant or breastfeeding\n3. Current history of smoking\n4. Alcohol intake \\> 21 units per week\n5. 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.\n6. Oxygen saturation \\\u003C95% breathing room air\n7. Abnormal findings on history, examination or laboratory tests suggestive of underlying illness (in the opinion of the clinician undertaking screening)\n8. History of recurrent vaso-vagal episodes\n9. Allergy to Imatinib\n10. Positive or equivocal hepatitis B or C serology result",true,"ALL","18 Years","40 Years",{"count":67,"type":68},65,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE1","PHASE2","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.\n\nThis study is a randomised clinical study investigating intravenous fluid therapy and oral imatinib therapy in healthy human volunteers exposed to intravenous lipopolysaccharide (LPS).\n\nThe objective of the study is to investigate the biological effects of fluid and imatinib therapy on LPS-induced microcirculatory dysfunction.",[75,76,77,78],"Sepsis","Fluid Overload","Endothelial Dysfunction","Microcirculation",[80,31],"Intravenous Fluid Therapy","NOT_YET_RECRUITING","2024-10-02",{"date":84,"type":85},"2024-10-04","ACTUAL",{"date":87,"type":68},"2024-12-01",{"date":89,"type":68},"2026-07-01",{"name":5,"class":6}]