[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652974":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":26,"locations":32,"responsibleParty":47,"collaborators":18,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":18,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":35,"whyStopped":18,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Intermountain Health Care, Inc.","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NICOM Fluid Assessment","ACTIVE_COMPARATOR","NICOM fluid assessment",[13],"Other: Non-Invasive Cardiac Output Monitoring (NICOM)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","Participants will not receive any research intervention",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Non-Invasive Cardiac Output Monitoring (NICOM)","Trained study team members will perform a NICOM fluid assessment. This assessment involves performing a passive leg raise while measuring change in stroke volume (SV) with the non-invasive cardiac output monitor (NICOM). A SV change \\>=10% during the passive leg raise indicates a patient is fluid responsive. The results of the NICOM fluid assessment will be provided to the patient's treating physician",[9],[25],"NICOM",[27],{"name":28,"role":29,"phone":30,"phoneExt":18,"email":31},"Elizabeth Munroe, MD","CONTACT","801-408-1991","elizabeth.munroe@imail.org",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":18},"Intermountain Medical Center Emergency Department","RECRUITING","Murray","Utah","84107","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-111.88799,40.66689,{"lat":45,"lon":44},{"type":48,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100652974","personalized-fluid-resuscitation-in-the-emergency-department-a-pilot-trial-100652974",false,"NCT07779720","Personalized Fluid Resuscitation in the Emergency Department: A Pilot Trial","Personalized Fluid Resuscitation for Improved Sepsis Resuscitation Quality in the Emergency Department","FLUID-ED","Inclusion Criteria:\n\n1. Adult patient being treated in the Intermountain Medical Center ED\n2. Patient has suspected sepsis. Suspected sepsis can be identified by a positive sepsis screen (standard screen completed by ED triage nurse), an active sepsis alert (which is triggered based on qualifying information or active by an ED nurse), or clinician report that patient has possible sepsis\n3. Patient is hypotensive OR has an initial lactate ≥4 mmol\u002FL at the time of enrollment. Hypotension is defined as mean arterial pressure (MAP) \\\u003C65 mmHg or systolic blood pressure (SBP) \\\u003C90mmHg or patient is on vasopressors at time of enrollment.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Known pregnant patients\n3. Patients who are known to be incarcerated\n4. A trained and delegated study team member is not available to perform the NICOM fluid assessment\n5. Patient has been in the ED for \\>6 hours or was transferred from an outside ED\n6. Patient has already received 30 ml\u002Fkg IV fluid or has this fluid volume ordered. Weight-based fluid dosing is calculated based on actual body weight for BMI \\\u003C30kg\u002Fm2 and ideal body weight for BMI ≥30 kg\u002Fm2\n7. Known clinical diagnosis of a condition potentially altering risk\u002Fbenefit profile of NICOM-based fluid assessment, which may include\n\n   1. Hemorrhagic shock (i.e.., active hemorrhage)\n   2. Cardiogenic shock (i.e., hypotension suspected to be due to left or right ventricular failure)\n   3. Obstructive shock (i.e., shock in the setting of known acute central pulmonary embolism, pneumothorax, or pericardial effusion)\n   4. Active volume loss that requires fluid replacement per the treating clinician (i.e., injury due to burn)\n   5. Acute stroke\n   6. Acute myocardial infarction\n   7. Status asthmaticus\n   8. Status epilepticus\n   9. Presence of a left ventricular assist device (LVAD)\n   10. Severe aortic insufficiency\n8. Known clinical contraindication to passive leg raise.\n\n   1. Lower extremity amputation\n   2. Lower extremity trauma\n   3. Open abdomen\n   4. Suspected or known elevated intracranial pressure, for example from intracranial hemorrhage, tumor, or traumatic brain injury\n   5. Contraindication to lying flat\n   6. Inability to cooperate with the maneuver (e.g., severe pain, agitation).\n9. Contraindication to non-invasive cardiac output monitoring (NICOM) lead placement.\n\n   1. Allergy to adhesive used in the NICOM lead stickers\n   2. Skin breakdown precluding lead placement on the patient's chest and back\n10. Treating clinician determines that NICOM assessment is either required or contraindicated for the optimal care of the patient","ALL","18 Years",{"count":60,"type":61},40,"ESTIMATED","INTERVENTIONAL",[64],"NA","The goal of this pilot clinical trial is to learn if a fluid assessment using non-invasive cardiac output monitoring (NICOM) is helpful for patients with sepsis who have low blood pressure in the Emergency Department (ED). The study will measure whether the NICOM assessment changes fluid resuscitation practices and is feasible in the ED setting. All patients will receive standard medical care. Patients assigned to the NICOM group will receive a one-time, non-invasive bedside fluid assessment using NICOM, in addition to standard care, and the results of the fluid assessment will be provided to the treating physician.",[67,68],"Sepsis","Septic Shock",[67,70],"septic shock","2026-08-19",{"date":73,"type":74},"2026-08-21","ACTUAL",{"date":76,"type":61},"2026-08",{"date":78,"type":61},"2028-05-01",{"name":5,"class":6},1]