[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100520879":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":12,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":12,"enrollmentInfo":59,"targetDuration":12,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":12,"overallStatus":33,"whyStopped":12,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Compartor arm","NO_INTERVENTION","\\- Patients allocated to the usual care group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP \\>65 mmHg, HR (heart rate) \\\u003C120 beats per minute (BPM), arterial oxygen saturation (SaO2) \\>94%, Hb \\> 7 gr\u002Fdl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Capillary-refill time and phenotyping group","ACTIVE_COMPARATOR","Patients w\u002Fnormal baseline CRT will be periodically monitored. Patients with abnormal CRT and septic shock will be categorized according to pulse pressure (PP). If \\\u003C40 mmHg, will go to fluid responsiveness (FR) assessment. FR (-) patients will undergo cardiac echo to rule out significant dysfunction. Fluid boluses will be administered in 30 min intervals and repeated as needed if CRT is still abnormal. Patients with PP ≥40 mmHg will proceed according to diastolic pressure (DAP). If ≥50 mmHg will move to FR assessment. If \\\u003C50 mmHg NE will be increased for MAP \\>65 mmHg and DAP ≥50 mmHg w\u002FCRT assessed 1 h after. NE will be increased in 0.1 mcg\u002Fk\u002Fm increments up to 0.5 mcg\u002Fk\u002Fm.\n\nIf CRT is normal, patients will proceed to periodic monitoring. Patients with persistent abnormal CRT or that reached NE safety limit will proceed directly to echo.\n\nPatients that correct CRT with first tier interventions will not be subjected to obligatory echo but will just proceed to periodic monitoring.",[18],"Other: Usual care (UC)",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Usual care (UC)","\\- Patients allocated to the UC group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP \\>65 mmHg, heart rate (HR) \\\u003C120 beats per minute (BPM), arterial oxygen saturation (SaO2) \\>94%, Hb \\> 7 gr\u002Fdl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Olfa MD Hamzaoui, PhD","CONTACT","0033310736973","ohamzaoui@chu-reims.fr",[31],{"facility":32,"status":33,"city":34,"state":12,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Hôpital Robert Debré, Université de Reims","RECRUITING","Reims","51092","France","FR",{"type":39,"coordinates":40},"Point",[41,42],4.02853,49.26526,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":28,"phoneExt":12,"email":29},"Hamzaoui MD Olfa, PhD",{"type":48,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100520879","hemodynamic-phenotype-basedcapillary-refill-time-targeted-resuscitation-in-early-septic-shockandromeda-shock-2-100520879",false,"NCT06062303","Hemodynamic Phenotype-Based,Capillary Refill Time-Targeted Resuscitation In Early Septic Shock:ANDROMEDA-SHOCK-2","Hemodynamic Phenotype-Based, Capillary Refill Time-Targeted Resuscitation In Early Septic Shock: The ANDROMEDA-SHOCK-2 Randomized Clinical Trial (A2)","ANDROMEDA-FR","Inclusion Criteria:\n\n* Consecutive adult patients (≥ 18 years)\n* Patients with septic shock according to Sepsis-3 consensus conference. In short, septic shock is defined as suspected or confirmed infection, plus hyperlactatemia and NE requirements due to persistent hypotension, after a fluid load of at least 1000mL in 1h\n* Patient and\u002For relative informed and having signed the information and consent form for participation in the study\n\nExclusion Criteria:\n\n* More than 4 hours since septic shock diagnosis,\n* Anticipated surgery or acute hemodialysis procedure to start during the 6h intervention period\n* Active bleeding,\n* Do not resuscitate status,\n* Child B-C Cirrhosis\n* Underlying disease process with a life expectancy \\\u003C 90 days and\u002For the attending clinician deems aggressive resuscitation unsuitable\n* Refractory shock (high risk of death within 24h)\n* Pregnancy\n* Concomitant severe acute respiratory distress syndrome\n* Patients in whom CRT cannot be accurately assessed\n* Non-affiliation to a social security scheme or to another social protection scheme\n* Patient on AME (state medical aid) (unless exemption from affiliation\n* Patient under legal protection (guardianship, curatorship)\n* Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable\n* Inability, according to the investigator, to understand the study (non-French-speaking patient, cognitive disorders)","ALL","18 Years",{"count":60,"type":61},180,"ESTIMATED","INTERVENTIONAL",[64],"NA","Over-resuscitation including fluid overload has been associated with increased morbidity (prolonged duration of organ failure) and mortality in septic shock. \"One-size-fits-all\" resuscitation strategies may increase septic shock mortality. However, clinical studies on individualized resuscitation are lacking. Hemodynamic phenotyping may allow to individualize septic shock resuscitation. The ANDROMEDA-SHOCK trial found that a simple clinical and bedside CRT-targeted resuscitation reduces organ dysfunction and 28-day mortality in septic shock. The current study will examine the hypothesis that a CRT-targeted resuscitation based on hemodynamic phenotyping considering within an decision tree usual bedside clinical parameters such as pulse pressure, diastolic blood pressure, fluid responsiveness and cardiac performance can further decrease mortality in septic shock as compared to usual care.",[67,68],"Intensive Care Unit Acquired Weakness","Shock, Septic","2024-12-03",{"date":71,"type":72},"2024-12-05","ACTUAL",{"date":74,"type":72},"2024-02-06",{"date":76,"type":61},"2026-05-30",{"name":5,"class":6},1]