Nctid:
NCT06234592
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012772", "term"=>"Shock, Septic"}, {"id"=>"D000058186", "term"=>"Acute Kidney Injury"}, {"id"=>"D000012769", "term"=>"Shock"}], "ancestors"=>[{"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000051437", "term"=>"Renal Insufficiency"}, {"id"=>"D000007674", "term"=>"Kidney Diseases"}, {"id"=>"D000014570", "term"=>"Urologic Diseases"}, {"id"=>"D000052776", "term"=>"Female Urogenital Diseases"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000052801", "term"=>"Male Urogenital Diseases"}, {"id"=>"D000018805", "term"=>"Sepsis"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000018746", "term"=>"Systemic Inflammatory Response Syndrome"}, {"id"=>"D000007249", "term"=>"Inflammation"}], "browseLeaves"=>[{"id"=>"M28998", "name"=>"Acute Kidney Injury", "asFound"=>"Acute Kidney Injury", "relevance"=>"HIGH"}, {"id"=>"M15577", "name"=>"Shock", "asFound"=>"Shock", "relevance"=>"HIGH"}, {"id"=>"M15580", "name"=>"Shock, Septic", "asFound"=>"Septic Shock", "relevance"=>"HIGH"}, {"id"=>"M26718", "name"=>"Renal Insufficiency", "relevance"=>"LOW"}, {"id"=>"M10698", "name"=>"Kidney Diseases", "relevance"=>"LOW"}, {"id"=>"M17319", "name"=>"Urologic Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M27095", "name"=>"Male Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M20864", "name"=>"Sepsis", "relevance"=>"LOW"}, {"id"=>"M16869", "name"=>"Toxemia", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M20818", "name"=>"Systemic Inflammatory Response Syndrome", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014667", "term"=>"Vasopressins"}, {"id"=>"D000001127", "term"=>"Arginine Vasopressin"}, {"id"=>"D000009638", "term"=>"Norepinephrine"}, {"id"=>"D000000804", "term"=>"Angiotensin II"}, {"id"=>"C000627694", "term"=>"Giapreza"}, {"id"=>"D000000808", "term"=>"Angiotensinogen"}], "ancestors"=>[{"id"=>"D000000316", "term"=>"Adrenergic alpha-Agonists"}, {"id"=>"D000000322", "term"=>"Adrenergic Agonists"}, {"id"=>"D000018663", "term"=>"Adrenergic Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000013566", "term"=>"Sympathomimetics"}, {"id"=>"D000001337", "term"=>"Autonomic Agents"}, {"id"=>"D000018373", "term"=>"Peripheral Nervous System Agents"}, {"id"=>"D000014662", "term"=>"Vasoconstrictor Agents"}, {"id"=>"D000006490", "term"=>"Hemostatics"}, {"id"=>"D000003029", "term"=>"Coagulants"}, {"id"=>"D000050034", "term"=>"Antidiuretic Agents"}, {"id"=>"D000045283", "term"=>"Natriuretic Agents"}, {"id"=>"D000015842", "term"=>"Serine Proteinase Inhibitors"}, {"id"=>"D000011480", "term"=>"Protease Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M12575", "name"=>"Norepinephrine", "asFound"=>"Finger", "relevance"=>"HIGH"}, {"id"=>"M4132", "name"=>"Angiotensin II", "asFound"=>"Blinded Study", "relevance"=>"HIGH"}, {"id"=>"M289354", "name"=>"Giapreza", "asFound"=>"Blinded Study", "relevance"=>"HIGH"}, {"id"=>"M4135", "name"=>"Angiotensinogen", "asFound"=>"Blinded Study", "relevance"=>"HIGH"}, {"id"=>"M17414", "name"=>"Vasopressins", "asFound"=>"Native", "relevance"=>"HIGH"}, {"id"=>"M4437", "name"=>"Arginine Vasopressin", "asFound"=>"Native", "relevance"=>"HIGH"}, {"id"=>"M17409", "name"=>"Vasoconstrictor Agents", "relevance"=>"LOW"}, {"id"=>"M4854", "name"=>"Benzocaine", "relevance"=>"LOW"}, {"id"=>"M20746", "name"=>"Adrenergic Agents", "relevance"=>"LOW"}, {"id"=>"M3668", "name"=>"Adrenergic alpha-Agonists", "relevance"=>"LOW"}, {"id"=>"M3673", "name"=>"Adrenergic Agonists", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}, {"id"=>"M16345", "name"=>"Sympathomimetics", "relevance"=>"LOW"}, {"id"=>"M9576", "name"=>"Hemostatics", "relevance"=>"LOW"}, {"id"=>"M6259", "name"=>"Coagulants", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M18391", "name"=>"Serine Proteinase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T433", "name"=>"Tannic Acid", "relevance"=>"LOW"}, {"id"=>"T1", "name"=>"Arginine", "relevance"=>"LOW"}, {"id"=>"T18", "name"=>"Serine", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Natriuretic Agents", "abbrev"=>"NaAg"}, {"name"=>"Coagulants", "abbrev"=>"Coag"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}, {"name"=>"Amino Acids", "abbrev"=>"AA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>45}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-07", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-28", "studyFirstSubmitDate"=>"2024-01-03", "studyFirstSubmitQcDate"=>"2024-01-28", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"otherOutcomes"=>[{"measure"=>"Perfused vessel density (PVD) measured in millimetres per square millimetre", "timeFrame"=>"Measured at +1 hour and +24 hours following study vasopressor infusion starting", "description"=>"Incident dark field video microscopy measures of the systemic microcirculation"}, {"measure"=>"Microvascular flow index (MFI) (unitless score from 0 to 3 where 3 is the value see in health).", "timeFrame"=>"Measured at +1 hour and +24 hours following study vasopressor infusion starting", "description"=>"Incident dark field video microscopy measures of the systemic microcirculation"}, {"measure"=>"Syndecan 1, angiopoietin 1 & 2, Interleukin 6 & 8 (IL-6, IL-8) and tissue necrosis factor (TNF). All measured in nanograms per millilitre (ng/ml)", "timeFrame"=>"Measured at baseline and +24 hours following study vasopressor infusion starting", "description"=>"Biomarker analysis - markers of inflammation and endothelial activation/function"}], "primaryOutcomes"=>[{"measure"=>"Cortical mean transit time (mTT) measured in seconds", "timeFrame"=>"Measured at +24 hours following study vasopressor infusion starting", "description"=>"Contrast enhanced ultrasound measure of renal cortical tissue blood flow"}], "secondaryOutcomes"=>[{"measure"=>"Cortical mean transit time (mTT) measured in seconds", "timeFrame"=>"Measured at +1 hour and +24 hours following study vasopressor infusion starting", "description"=>"Contrast enhanced ultrasound measures of renal cortical tissue blood flow"}, {"measure"=>"Cortical perfusion index (PI) measured in arbitrary units", "timeFrame"=>"Measured at +1 hour and +24 hours following study vasopressor infusion starting", "description"=>"Contrast enhanced ultrasound measures of renal cortical tissue blood flow"}, {"measure"=>"Cortical wash in rate (WiR) measured in arbitrary units", "timeFrame"=>"Measured at +1 hour and +24 hours following study vasopressor infusion starting", "description"=>"Contrast enhanced ultrasound measures of renal cortical tissue blood flow"}, {"measure"=>"Urinary oxygen tension (pO2) across 24 hours study period measured in millimetres of mercury (mmHg)", "timeFrame"=>"Across 24 hours study period", "description"=>"Mean urinary pO2"}, {"measure"=>"Tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth factor binding protein-7 (IGFBP-7). Both measured in nanograms per millilitre (ng/ml)", "timeFrame"=>"Measured at baseline and +24 hours following study vasopressor infusion starting", "description"=>"Biomarker analysis - regulatory proteins involved in initiating cell cycle arrest and associated with AKI"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Septic Shock", "Acute Kidney Injury"]}, "descriptionModule"=>{"briefSummary"=>"Acute kidney injury (AKI) is a common complication of septic shock and together these conditions carry a high mortality risk. In septic patients who develop severe AKI renal cortical perfusion is deficient despite normal macrovascular organ blood flow. This intra-renal perfusion abnormality may be amenable to pharmacological manipulation, which may offer mechanistic insight into the pathophysiology of septic AKI. The aim of the current study is to investigate the effects of vasopressin and angiotensin II on renal microcirculatory perfusion in a cohort of patients with septic shock."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Within 48 hours of intensive care admission\n* Evidence of suspected or confirmed infection\n* Sequential Organ Failure (SOFA) score increase of 2 or more (assuming a baseline of 0 if no previous measures)\n* Requirement for norepinephrine infusion as the sole vasopressor agent in a dose of \\>0.1mcg/kg/min\n* Lactate \\>2mmol/L at any stage prior to randomisation\n\nExclusion Criteria:\n\n* Known intolerance to Sonovue™ contrast medium, vasopressin or angiotensin II\n* Patients receiving other vasoactive drugs in addition to norepinephrine\n* Patients with known chronic kidney disease (CKD) stage 4 or 5 (baseline glomerular filtration rate (GFR) \\<30mls/min)\n* Patients receiving extra corporal membrane oxygenation (ECMO)\n* Patients with acute occlusive coronary syndromes requiring intervention\n* Patients with mesenteric ischaemia\n* Patients with a history or presence of aortic dissection or abdominal aortic aneurysm\n* Patients with Raynaud's syndrome or acute vaso-occlusive conditions\n* Pregnancy"}, "identificationModule"=>{"nctId"=>"NCT06234592", "acronym"=>"REPERFUSE", "briefTitle"=>"The Effect of Vasopressor Therapy on Renal Perfusion in Septic Shock", "organization"=>{"class"=>"OTHER", "fullName"=>"King's College Hospital NHS Trust"}, "officialTitle"=>"The Effect of Vasopressor Therapy on Renal Perfusion in Patients With Septic Shock - a Mechanistically Focussed Randomized Control Study", "orgStudyIdInfo"=>{"id"=>"328797"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Angiotensin II Infusion", "description"=>"Angiotensin II infusion commenced alongside standard care vasopressor therapy (norepinephrine). Angiotensin II up titrated in a protocolised manner to a target/maximum dose of 40 ng/kg/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.", "interventionNames"=>["Drug: Angiotensin II", "Drug: Norepinephrine"]}, {"type"=>"EXPERIMENTAL", "label"=>"Vasopressin Infusion", "description"=>"Vasopressin infusion commenced alongside standard care vasopressor therapy (norepinephrine). Vasopressin up titrated in a protocolised manner to a target/maximum dose of 0.04 IU/min whilst noradrenaline down titrated in order to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.", "interventionNames"=>["Drug: Vasopressin", "Drug: Norepinephrine"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Norepinephrine Infusion", "description"=>"Standard care vasopressor therapy which recruited participants already receiving, titrated to achieve/maintain target mean arterial pressure (MAP) as directed by attending clinician.", "interventionNames"=>["Drug: Norepinephrine"]}], "interventions"=>[{"name"=>"Angiotensin II", "type"=>"DRUG", "description"=>"Angiotensin II infusion", "armGroupLabels"=>["Angiotensin II Infusion"]}, {"name"=>"Vasopressin", "type"=>"DRUG", "description"=>"Vasopressin infusion", "armGroupLabels"=>["Vasopressin Infusion"]}, {"name"=>"Norepinephrine", "type"=>"DRUG", "description"=>"Standard care vasopressor therapy, norepinephrine infusion", "armGroupLabels"=>["Angiotensin II Infusion", "Norepinephrine Infusion", "Vasopressin Infusion"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"SE5 9RS", "city"=>"London", "country"=>"United Kingdom", "contacts"=>[{"name"=>"Sam Hutchings", "role"=>"CONTACT", "email"=>"sam.hutchings@nhs.net", "phone"=>"02032994957"}], "facility"=>"King's College Hospital", "geoPoint"=>{"lat"=>51.50853, "lon"=>-0.12574}}], "centralContacts"=>[{"name"=>"Sam Hutchings", "role"=>"CONTACT", "email"=>"sam.hutchings@nhs.net", "phone"=>"02032994957"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"King's College Hospital NHS Trust", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"European Society of Intensive Care Medicine", "class"=>"OTHER"}, {"name"=>"Royal Centre for Defence Medicine", "class"=>"OTHER_GOV"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
