[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477052":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":53,"collaborators":23,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":23,"enrollmentInfo":65,"targetDuration":23,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":23,"overallStatus":39,"whyStopped":23,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Rhode Island Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hour-1 Bundle","ACTIVE_COMPARATOR","If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the Hour-1 bundle, all interventions in the bundle must be initiated within 1 hour.",[13],"Other: Sepsis Bundle",{"label":15,"type":10,"description":16,"interventionNames":17},"3-Hour Bundle","If the patient meets 2+ SIRS and chief complaint criteria, a second BPA may be triggered, which displays to the provider. The second alert identifies patients who progress to organ failure based on lab results, or who have a recorded instance of hypotension. When this alert appears, an automatic counter will begin and serve as our Sepsis Time Zero. The provider will receive sepsis order sets and guided to the Sepsis Navigator. The navigator will allow them to review relevant patient data, reference sepsis guidelines, and keep tabs on a live-updating sepsis checklist to ensure they complete each element in order and on time. Following identification in the ED, both study arms will receive the same bundle (see below). The only difference will be the timing: For the 3-hour bundle, all elements must be completed by 3 hours.",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Sepsis Bundle","Intervention initiated within 1 hour or 3 hours of presentation depending on the Arm: 1. Measure lactate level. 2. Obtain blood cultures before administering antibiotics. 3. Administer broad-spectrum antibiotics. 4. Begin rapid administration of 30ml\u002Fkg crystalloid for hypotension or lactate greater than or equal to 4mmol\u002FL. 5. Apply vasopressor if hypotensive during or after fluid resuscitation to maintain a mean arterial pressure greater than or equal to 65 mm Hg.",[15,9],null,[25],{"name":26,"affiliation":5,"role":27},"Mitchell Levy, MD","PRINCIPAL_INVESTIGATOR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},"CONTACT","401-444-4000","mitchell_levy@brown.edu",{"name":34,"role":30,"phone":35,"phoneExt":23,"email":36},"Lori Harmon, RRT, MBA, CPHQ","847-493-6403","lharmon@sccm.org",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"RECRUITING","Providence","Rhode Island","02903","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-71.41283,41.82399,{"lat":49,"lon":48},[52],{"name":26,"role":30,"phone":31,"phoneExt":23,"email":32},{"type":27,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Mitchell Levy","Director of Critical Care Medicine at Lifespan, and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine","100477052","assessment-for-implementation-methods-in-sepsis-100477052",false,"NCT05491941","Assessment for Implementation Methods in Sepsis","AIMS","Inclusion Criteria:\n\n* Adults \\>=18\n* Patient meets criteria for time zero (sepsis within 6 hours of ED triage and the 3 criteria-infection, 2 SIRS and 1 or more organ dysfunctions, must be met within 3 hours of each other.\n\nExclusion Criteria:\n\n* Last admission for patients admitted to same hospital once\n* Pregnant women\n* All transfers from another hospital\n* Individuals who are made comfort care only within 6 hours of admission to ED\n* Moribund patients","ALL","18 Years",{"count":66,"type":67},10000,"ESTIMATED","INTERVENTIONAL",[70],"NA","Since the introduction of sepsis bundles, there have been multiple published trials that have demonstrated a consistent, strong association between implementation of sepsis \"bundles\" (3-hour bundle) and improved survival. The current proposal is a Hybrid 2, pragmatic, cluster randomized clinical effectiveness\u002Fimplementation trial evaluating mortality and respiratory failure-based outcomes, in patients admitted to the emergency department with sepsis, comparing the effectiveness of implementation of the hour-1 bundle to 3-hour bundle, while facilitating adherence to both bundles. In addition, 4 distinct sepsis phenotypes will be derived from routine clinical data to identify specific patient phenotypes that allow for a more precision-based application of sepsis bundles in future studies.",[73,74],"Sepsis Severe","Septic Shock","2022-08-04",{"date":77,"type":78},"2022-08-08","ACTUAL",{"date":80,"type":78},"2022-07-15",{"date":82,"type":67},"2027-07-15",{"name":5,"class":6},1]