[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554485":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":30,"locations":36,"responsibleParty":66,"collaborators":10,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":10,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":10,"enrollmentInfo":78,"targetDuration":10,"studyType":81,"phases":10,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ringer's Lactate",null,"Adult patients admitted in the intensive care unit (ICU) with sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation (i.e., 30 ml\u002Fkg crystalloid).",[13],"Drug: Ringer's Lactate",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Ringer's Lactate is administered at a dose of 30ml\u002Fkg, with the first 20ml\u002Fkg given at a constant rate over the initial 30 minutes, followed by a 30-minute pause, and then an additional 10ml\u002Fkg over the next 15 minutes, completing the infusion within 75 minutes.",[9],[20],"Crystalloid",[22,26],{"name":23,"affiliation":24,"role":25},"Robert Hahn, Professor","Karolinska Institutet: Stockholm, SE (Department of Clinical Sciences, Danderyd Hospital) Employment","STUDY_CHAIR",{"name":27,"affiliation":28,"role":29},"Serban-Ion Bubenek-Turconi, Professor","\"Prof CC Iliescu\" Emergency Institue for Cardiovascular Diseases","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":10,"email":35},"Cosmin Balan, PhD","CONTACT","0722751501","cosmin13mara@yahoo.com",[37,56],{"facility":38,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Fundeni Clinical Institute","RECRUITING","Bucharest","022328","Romania","RO",{"type":45,"coordinates":46},"Point",[47,48],26.10626,44.43225,{"lat":48,"lon":47},[51,54],{"name":52,"role":33,"phone":10,"phoneExt":10,"email":53},"Sebastian Isac, PhD","sebastian.isac@umfcd.ro",{"name":52,"role":55,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"facility":28,"status":39,"city":40,"state":10,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":45,"coordinates":58},[47,48],{"lat":48,"lon":47},[61,63,65],{"name":32,"role":33,"phone":62,"phoneExt":10,"email":35},"+40722751501",{"name":10,"role":33,"phone":10,"phoneExt":64,"email":35},"Balan",{"name":32,"role":55,"phone":10,"phoneExt":10,"email":10},{"type":55,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Balan Ion Cosmin","Principal Investigator","100554485","volume-kinetics-of-fluid-resuscitation-in-early-sepsis-100554485",false,"NCT06499701","Volume Kinetics of Fluid Resuscitation in Early Sepsis","Volume Kinetics of Fluid Resuscitation With 30 ml\u002Fkg Ringer Lactate in Early Sepsis","Inclusion Criteria:\n\nA diagnosis of sepsis, as defined by the Sepsis-3 criteria and exhibiting sepsis-induced hypoperfusion prior to the administration of adequate volume resuscitation:\n\n* hypotension requiring norepinephrine to maintain a mean arterial blood pressure (MAP) either predefined by the clinician or at 65 mm Hg or higher and\u002For\n* a serum lactate level \\>2 mmol\u002FL (18mg\u002FdL) and\u002For\n* acute oliguria defined as urine output \\\u003C0.5mL\u002Fkg\u002Fhr and\u002For\n* mottled skin and\u002For\n* capillary refill time \\> 3 seconds.\n\nExclusion Criteria:\n\n* Administration of at least 1 L of IV fluid in the last 6 hours prior to screening. All crystalloids, colloids and blood products that the patient has received are counted.\n* Known pregnancy.\n* Competing causes of lactic acidosis including: seizures within 3 hours of enrollment, use of linezolid or metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders.\n* End-stage renal disease that requires chronic dialysis.\n* Concurrent haemorrhagic or obstructive shock.\n* Increased risk of fluid intolerance:\n\n  * Echocardiographic evidence of moderate or severe left ventricular systolic dysfunction.\n  * Echocardiographic evidence of moderate or severe right ventricular systolic dysfunction.\n  * Hypoxemia index \\\u003C 200 mmHg or sonographic evidence of bilateral B or C profile.\n  * Abdominal compartment syndrome.\n* Post-cardiac arrest.","ALL","18 Years",{"count":79,"type":80},15,"ESTIMATED","OBSERVATIONAL","The recommended volume resuscitation for patients with early sepsis-induced hypoperfusion is at least 30 ml\u002Fkg of crystalloid administered within the first three hours. However, this standardized approach does not account for individual patient variability and lacks personalization. Additionally, the effects of administering 30 ml\u002Fkg on intercompartmental fluid shifts between the plasma and interstitial compartments remain unclear. This study aims to describe the volume kinetics of administering 30 ml\u002Fkg of Ringer's Lactate in patients with early sepsis-induced hypoperfusion within the first three hours.",[84],"Fluid and Electrolyte Imbalance",[86,87,88,89,9],"volume kinetics","sepsis","volume resuscitation","crystalloid","2026-03-16",{"date":92,"type":93},"2026-03-18","ACTUAL",{"date":95,"type":93},"2024-06-19",{"date":97,"type":80},"2026-07-30",{"name":5,"class":6},2]