[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100218248":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":45,"centralContacts":49,"locations":58,"responsibleParty":82,"collaborators":32,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":32,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":32,"enrollmentInfo":93,"targetDuration":32,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":61,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Chicago","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Norepinephrine and epinephrine","ACTIVE_COMPARATOR","Patients will receive norepinephrine infusion per standard protocol. Dose range will be 0.03-0.3 mcg\u002Fkg\u002Fminute. Norepinephrine concentration will be 16 mg\u002F250 mL. If a second vasopressor is required, epinephrine will be added. Dose range of epinephrine will be 0.03-0.3 mcg\u002Fkg\u002Fminute. Epinephrine concentration will be 16 mg\u002F250 mL. The drugs norepinephrine and epinephrine will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL\u002Fhr; this will allow the bedside nurse to program the medication per standard protocol.\n\nIf the patient's shock is not adequately treated with the highest doses of both norepinephrine and epinephrine, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.",[13,14],"Drug: Norepinephrine","Drug: Epinephrine",{"label":16,"type":10,"description":17,"interventionNames":18},"Phenylephrine and vasopressin","Patients will receive phenylephrine infusion per standard protocol. Dose range will be 0.3 to 3.0 mcg\u002Fkg\u002Fminute. Phenylephrine concentration will be 160 mg\u002F250 mL. If a second vasopressor is required, vasopressin will be added. Dose range of vasopressin will be 0.1 to 0.6 milliunits\u002Fkg\u002Fminute. Vasopressin concentration will be 40 units\u002F250 mL. The drugs phenylephrine and vasopressin will be mixed and blinded by the research pharmacy. The research pharmacist will list the dose ranges in mL\u002Fhr; this will allow the bedside nurse to program the medication per standard protocol.\n\nIf the patient's shock is not adequately treated with the highest doses of both phenylephrine and vasopressin, additional, open-label norepinephrine will be added, and titrated to achieve target blood pressure. If the patient's shock is not adequately treated with three vasopressors, additional open-label epinephrine will be added, and titrated to achieve target blood pressure.",[19,20],"Drug: Phenylephrine","Drug: Vasopressin",[22,29,33,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Norepinephrine","Dose range 0.03 to 0.3 mcg\u002Fkg\u002Fminute, titrated to target blood pressure.",[9],[28],"Levophed",{"type":23,"name":30,"description":25,"armGroupLabels":31,"otherNames":32},"Epinephrine",[9],null,{"type":23,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Phenylephrine","Dose range 0.3 to 3.0 mcg\u002Fkg\u002Fminute, titrated to target blood pressure.",[16],[38],"Neo-Synephrine",{"type":23,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Vasopressin","Dose range 0.1 to 0.6 milliunits\u002Fkg\u002Fminute, titrated to target blood pressure.",[16],[44],"Pitressin",[46],{"name":47,"affiliation":5,"role":48},"John P Kress, MD","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":32,"email":53},"CONTACT","773-702-6404","jkress@medicine.bsd.uchicago.edu",{"name":55,"role":51,"phone":56,"phoneExt":32,"email":57},"Anne Pohlman","6302487461","apohlman@medicine.bsd.uchicago.edu",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"University of Chicago Medical Center","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-87.65005,41.85003,{"lat":71,"lon":70},[74,75,78,79],{"name":47,"role":51,"phone":52,"phoneExt":32,"email":53},{"name":76,"role":51,"phone":77,"phoneExt":32,"email":57},"Anne S Pohlman, MSN","773-702-3804",{"name":47,"role":48,"phone":32,"phoneExt":32,"email":32},{"name":80,"role":81,"phone":32,"phoneExt":32,"email":32},"Jessica Cooksey, MD","SUB_INVESTIGATOR",{"type":83,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100218248","phase-4-vasoactive-drugs-in-intensive-care-unit-100218248",false,"NCT02118467","Vasoactive Drugs in Intensive Care Unit","A Randomized Double Blind Trial of Vasoactive Drugs for the Management of Shock in the ICU","Inclusion Criteria:\n\n1. Age greater than or equal to 18 years old\n2. Requirement for vasoactive drugs via a central venous catheter for the treatment of shock. Shock will be defined as mean arterial pressure less than 70 mmHg or systolic blood pressure less than 100 mmHg despite administration of at least 1000 mL of crystalloid or 500 mL of colloid, unless there is an elevation in the central venous pressure to \\> 12 mmHg or in the pulmonary artery occlusion pressure to \\> 14 mmHg coupled with signs of tissue hypoperfusion (e.g. altered mental state, mottled skin, urine output \\\u003C 0.5 mL\u002Fkg body weight for one hour, or a serum lactate level of \\> 2 mmol per liter).\n\nExclusion Criteria:\n\n1. Cardiopulmonary arrest\n2. Pregnancy\n3. Severe right heart failure","ALL","18 Years",{"count":94,"type":95},836,"ESTIMATED","INTERVENTIONAL",[98],"PHASE4","The investigators hypothesis is that for ICU patients with shock, the use of the vasoactive drugs phenylephrine and vasopressin will reduce tachydysrhythmias when compared to norepinephrine and epinephrine. To investigate this hypothesis, the investigators are conducting a randomized double blind controlled trial comparing phenylephrine and vasopressin vs. norepinephrine and epinephrine in ICU patients with shock that is not responsive to IV fluids. All patients admitted to the adult intensive care units at the University of Chicago will be screened for eligibility.",[101],"Shock",[101,103,24,30,34,40,104,105],"Vasopressor agents","Atrial fibrillation","Tachyarrhythmia","2026-01-12",{"date":108,"type":109},"2026-01-13","ACTUAL",{"date":111,"type":109},"2014-05-15",{"date":113,"type":95},"2026-12-01",{"name":5,"class":6},1]