[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100508262":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":82,"collaborators":25,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":25,"enrollmentInfo":96,"targetDuration":25,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Università Vita-Salute San Raffaele","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Renin-guided hemodynamic management","EXPERIMENTAL","We will measure serum renin values every six hours. If the measured renin concentration increases by more that 20% compared with the last value, the target mean arterial pressure (MAP) will be elevated to 75-80 mmHg. If the subsequent renin level is still rising, the target MAP will be further raised to 85-90 mmHg and the addition of inotropes will be considered. If the first subsequent renin level decreases or increases by ≤20%, the target MAP will be kept at 75-80 mmHg. If the renin level at the subsequent measurement after reaching the highest step of management protocol is still increasing, a failure of the intervention will be declared, the target MAP will return to 65-70 mmHg. If renin level further decreases or increases ≤20% for two consecutive measurements, we will downgrade the target MAP to the previous step.",[13],"Procedure: Renin-guided hemodynamic management",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual care","SHAM_COMPARATOR","Patients in the usual care group will be managed according to standard of practice at each participating center.",[19],"Procedure: Usual care",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","If normalization of renin levels is achieved (values within the normal laboratory range), we will continue with usual care according to local protocols.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Standard of care",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Alessandro Belletti, MD","CONTACT","0039 0226436151","belletti.alessandro@hsr.it",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Nicola Buzzatti, MD","buzzatti.nicola@hsr.it",[39,54,69],{"facility":40,"status":41,"city":42,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"University Hospital Dubrava","RECRUITING","Dubrava","Croatia","HR",{"type":46,"coordinates":47},"Point",[48,49],16.06361,45.83361,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":25,"phoneExt":25,"email":25},"Nikola Bradic, MD",{"facility":55,"status":56,"city":57,"state":58,"zip":25,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Ospedale Mater Domini","NOT_YET_RECRUITING","Catanzaro","Calabria","Italy","IT",{"type":46,"coordinates":62},[63,64],16.60086,38.88247,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":25,"phoneExt":25,"email":25},"Andrea Bruni, MD",{"facility":70,"status":41,"city":71,"state":25,"zip":72,"country":59,"countryCode":60,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"IRCCS Ospedale San Raffaele","Milan","20132",{"type":46,"coordinates":74},[75,76],9.18951,45.46427,{"lat":76,"lon":75},[79],{"name":31,"role":32,"phone":80,"phoneExt":81,"email":34},"0226436158","+39",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Giovanni Landoni","MD, Full Professor","100508262","renin-guided-hemodynamic-management-in-patients-with-shock-100508262",false,"NCT05898126","Renin-guided Hemodynamic Management in Patients With Shock","Effect of Personalized Hemodynamic Management Based on Serum Renin Concentration on Acute Kidney Injury Progression in Patients With Shock: a Randomized Controlled Trial.","RENIN","Inclusion Criteria:\n\n* ≥18 years old\n* Admitted to an intensive care unit (ICU)\n* Requiring norepinephrine infusion at any dose to maintain a mean arterial pressure (MAP) of ≥65 mmHg after initial fluid resuscitation\n* Expected to stay in the ICU for at least 24 hours\n* Written informed consent from the patient him-\u002Fherself or the patient's next of kin as requested by the ethics committee.\n\nExclusion Criteria:\n\n* Pregnancy\n* Refused informed consent\n* Current enrollment into another randomized controlled trial that does not allow concomitant enrollment\n* Requiring vasopressors for \\>12 hours before the enrollment\n* Renal failure with an imminent need for renal replacement therapy (RRT)\n* Intention to use RRT by clinical judgment despite lack of urgent clinical indication\n* AKI stage 2 and 3 at enrollment according to the KDIGO criteria\n* Prior enrollment in this study\n* Severe liver disease (Child-Pugh score \\>7 points)\n* Chronic kidney disease (CKD) equal to or worse than CKD stage IV (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* History of kidney transplant\n* Any condition explicitly requiring a higher or lower blood pressure target according to clinical judgment","ALL","18 Years",{"count":97,"type":98},800,"ESTIMATED","INTERVENTIONAL",[101],"NA","Shock is a major risk factor for mortality among patients admitted to intensive care units (ICUs). Since various hemodynamic strategies uniformly delivered to patients with shock have failed to improve clinically relevant outcomes, individualized approaches for shock supported by robust evidence are required. This study will be a prospective, multicenter, parallel-group, single-blind, randomized controlled trial. The investigators will randomly assign 800 critically ill patients requiring norepinephrine infusion to the renin-guided or usual care groups. The investigators hypothesize that renin-guided hemodynamic management, compared to usual care, can reduce a composite of mortality and acute kidney injury (AKI) progression in patients requiring vasopressor support.",[104],"Shock",[104,106,107,108,109,110,111,112],"Renin","Vasopressor","Lactate","Acute Kidney Injury","Intensive Care Unit","Mortality","Quality of life","2025-08-05",{"date":115,"type":116},"2025-08-06","ACTUAL",{"date":118,"type":116},"2025-01-27",{"date":120,"type":98},"2027-07-28",{"name":5,"class":6},3]