[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07616817":3,"trial-entities:NCT07616817":81,"trial-summary:NCT07616817":85},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":33,"maximum_age":33,"healthy_volunteers":33,"eligibility_criteria":49,"std_ages":58,"locations":62,"central_contacts":71,"overall_officials":72,"references":73,"see_also_links":74},"NCT07616817","7146","Delphi Septic Shock: Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock","Consensus Statements on Classification and Management of Hemodynamic Sub-phenotypes Using Point-of-Care Ultrasound in Patients With Septic Shock","ENROLLING_BY_INVITATION","2027-12-01","2026-05","2026-06-01","2025-12-05","Albany Medical College","OTHER",false,"The Delphi survey process is a well-established mechanism for generating consensus on a certain topic by using a panel \"collective intelligence\". The Steering Committee, made up of critical care physicians, will undertake a literature search on available information, including existing hemodynamic sub-phenotypes and the use of point-of-care ultrasound in the classification and management of septic shock. The Steering Committee will not participate in the Delphi surveys. The anonymity of the Experts will be maintained until the end of the Delphi rounds. Point-of-care ultrasound has been proposed as a quick bed-side tool to identify hemodynamic subphenotypes and may guide personalized management. However, there is a dearth of evidence supporting the presence of these subphenotypes and management recommendations (if any) based on these subphenotypes. Thus, the objective of this study would be to conduct a survey, using the Delphi method, to obtain a consensus from critical care experts on classification and management of hemodynamic cardiac and lung phenotypes.","Purpose:\n\nThis study proposes a modified Delphi-based approach to generate expert's consensus statements on the classification and the management of hemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.\n\nThe pathophysiology of septic shock involves alterations in volume dynamics, involving macro and microcirculation. Sepsis-induced cardiomyopathy, characterized by a global decrease in LV ejection fraction (LVEF) of less than 50% or a 10% drop from baseline, affects 40-50% of individuals with septic shock. At least in one explorational study, myocardial dysfunction was prevalent in all patients with septic shock when considering left ventricle (LV) systolic and diastolic, right ventricular (RV), and mixed failure. The presence of underlying chronic cardiac disease can further complicate hemodynamic presentation and management of patients with sepsis. Sepsis and pre-existing heart failure (HF) together worsen clinical outcomes due to the compounding effects of both conditions. Reciprocally, sepsis-induced cardiomyopathy can further worsen cardiac performance in patients with HF. This interplay highlights the need for tailored therapeutic strategies to address the dual burden of these conditions.\n\nAdditionally, many hemodynamic measurements previously used lack accuracy when applied to patients with sepsis. In 2016 guidelines, the Surviving Sepsis Campaign removed central venous pressure (CVP) assessment due to its limited ability to predict volume status within the normal range of 8 to 12 mm Hg, as this static hemodynamic measure is predictive of response to fluid administration only at extreme ranges. In patients with sepsis and pre-existing HF, CVP is even less accurate, as preload estimates depend on ventricular compliance. Right ventricular (RV) dysfunction can elevate CVP, while left ventricular (LV) dysfunction and pulmonary edema may have minimal impact. Similarly, the accuracy of pulse pressure variation (PPV) may be reduced by RV dysfunction or LV dysfunction, with the effects most pronounced in RV failure due to pulmonary hypertension.\n\nPoint-of-care ultrasound has been proposed as a quick bed-side tool to identify hemodynamic subphenotypes and may guide personalized management. However, there is a dearth of evidence supporting the presence of these subphenotypes and management recommendations (if any) based on these subphenotypes. We propose a modified Delphi-based approach to generate expert's consensus statements on the classification and the management of haemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.\n\nOBJECTIVES\n\n1. To generate consensus position statements on the classification of haemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock.\n2. To generate consensus position statements on the management of haemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.\n3. To identify research priorities for haemodynamic subphenotypes of septic shock.",[19,20,21],"Septic Shock","Sepsis","Shock",[23,24,25,26,27,28,29,30,31],"point-of-care ultrasound","delphi","hemodynamic management","echo phenotypes","septic shock","consensus","ultrasound","anesthesiology","critical care","OBSERVATIONAL",null,[],{"count":36,"type":37},50,"ESTIMATED",[],[40],{"measure":41,"description":42,"timeFrame":43},"Percentage of agreement on statements in Delphi rounds on the classification of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.","To generate consensus position statements on the classification of hemodynamic sub-phenotypes using point-of-care ultrasound and clinical assessment of patients with septic shock--based on percentage of agreement of the statements.","through study completion, on average, 6 months.",[45],{"measure":46,"description":47,"timeFrame":43},"Percentage of agreement on statements in Delphi rounds on the management of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock.","To generate consensus position statements on the management of hemodynamic sub-phenotypes using point-of-care ultrasound in patients with septic shock","ALL",{"inclusion":50,"exclusion":56,"raw_text":57},[51,52,53,54,55],"Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.","At least one publication on point-of-care ultrasound in critically ill patients","Accreditation\u002Fcertification\u002F institutional credentialing in point-of-care ultrasound or echocardiography.","Ten or more years of experience in point-of-care ultrasonography in critically ill patients. 35-50 International experts from six continents will be engaged in the Delphi process.","Concerted efforts will be made to ensure that at least 50% of the experts are from low-and middle-income countries and not more than 70% are from each sex.",[],"Inclusion Criteria:\n\n-Healthcare professionals with at least 30% of the clinical work commitment to managing critically ill patients.\n\nAND at least one of the following:\n\n* At least one publication on point-of-care ultrasound in critically ill patients\n* Accreditation\u002Fcertification\u002F institutional credentialing in point-of-care ultrasound or echocardiography.\n* Ten or more years of experience in point-of-care ultrasonography in critically ill patients. 35-50 International experts from six continents will be engaged in the Delphi process.\n* Concerted efforts will be made to ensure that at least 50% of the experts are from low-and middle-income countries and not more than 70% are from each sex.\n\nExclusion Criteria:\n\n* Expert candidates who do not meet detailed inclusion criteria",[59,60,61],"CHILD","ADULT","OLDER_ADULT",[63],{"facility":13,"city":64,"state":65,"zip":66,"country":67,"geoPoint":68},"Albany","New York","12208","United States",{"lat":69,"lon":70},42.65258,-73.75623,[],[],[],[75,78],{"label":76,"url":77},"Perioperative Management of Patients with Sepsis and Septic Shock, Part II: Ultrasound Support for Resuscitation.","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F32008647\u002F",{"label":79,"url":80},"Delphi methodology in healthcare research: How to decide its appropriateness","https:\u002F\u002Fpubmed.ncbi.nlm.nih.gov\u002F34322364\u002F",{"nct_id":4,"conditions":82,"biomarkers":84},[83,19,21],"Septicemia",[],{"nct_id":4,"found":15,"summary":33,"prompt_version":33}]