[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610627":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":47,"sex":53,"minAge":54,"maxAge":10,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Niguarda Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"ICU patients with a diagnosis of infection\u002Fsepsis\u002Fseptic shock",null,"* stage 3 KDIGO consensus criteria, indication to CRRT\n* use of at least one of the following antibiotics meropenem, linezolid and daptomycin",[13],"Diagnostic Test: Liquid Chromatography - Tandem Mass Spectrometry",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Liquid Chromatography - Tandem Mass Spectrometry","The samples will be processed by a company with expertise in antibiotic TDM. To ensure the highest standards of accuracy and reliability in our data, blood samples collected during this study will be evaluated using state-of-the-art Liquid Chromatography - Tandem Mass Spectrometry (LC-MS\u002FMS) techniques. This advanced analytical method allows for the precise quantification and identification of biochemical compounds within complex biological matrices, providing unparalleled sensitivity and specificity. Following collection, blood is centrifuged to separate serum or plasma, which is then aliquoted to avoid degradation from freeze-thaw cycles. Aliquots are stored at -80°C to preserve sample integrity until analysis. This meticulous pre-analytical preparation ensures that all samples can be analyzed simultaneously, reducing analytical variability, and maintaining the quality of the samples for LC-MS\u002FMS analysis",[9],[21],{"name":22,"affiliation":5,"role":23},"Sara Micol Santambrogio, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":10,"email":28},"CONTACT","+390264441","saramicol.santambrogio@ospedaleniguarda.it",[30],{"facility":5,"status":31,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":10},"RECRUITING","Milan","Italia","20162","Italy","IT",{"type":38,"coordinates":39},"Point",[40,41],12.59836,42.78235,{"lat":41,"lon":40},{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100610627","in-vivo-antibiotics-removal-during-hemoadsorption-cartridges-and-continuous-renal-replacement-therapy-in-the-intensive-care-unit-100610627",false,"NCT07230041","In Vivo Antibiotics Removal During Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit","In Vivo Antibiotics Removal During Treatment With Hemoadsorption Cartridges and Continuous Renal Replacement Therapy in the Intensive Care Unit","ICARO","Inclusion Criteria:\n\n* stage 3 KDIGO consensus criteria, indication to CRRT\n* use of at least one of the following antibiotics meropenem, linezolid and daptomycin\n* \\\u003C 18 yo\n\nExclusion Criteria:\n\n* \\\u003C 18 yo","ALL","18 Years",{"count":56,"type":57},20,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to measure the change in plasma concentrations of antibiotics used during passage through the CRRT filter and hemadsorption cartridge in patients with septic shock and renal failure requiring CRRT.\n\nAll patients aged \\> 18 years, admitted to the ICU, diagnosed with septic shock and renal failure requiring CRRT, receiving antibiotic therapy with at least one of the following drugs: meropenem, linezolid, and daptomycin, who provided informed consent, are included in the study.\n\nPatients not admitted to the ICU, patients with renal failure not requiring CRRT, patients aged \\\u003C 18 years, or those who did not provide informed consent are excluded. The enrollment period will last 12 months and will run from September 2024 to September 2025. The expected number of patients enrolled is twenty. To proceed with the study, after starting antibiotic therapy, a 4 ml dose of blood will be drawn (Vacuette tube ref. 454092) before the cartridge, immediately after, and after the dialysis filter. This measurement will be repeated after 4, 8, and 12 hours, which represents the maximum usage time of the cartridge.\n\nAfter 12 hours, the cartridge becomes saturated and loses its adsorption capacity.\n\nThe CRRT filter, however, remains in place for at least 72 hours before being replaced. Treatment is maintained until clinically necessary.\n\nFor patients in intensive care, several blood samples are required throughout the day, both with a blood sample sent to the biochemistry laboratory every 6-8 hours to check clinical conditions, and with an arterial blood sample (blood gas) to check respiratory and metabolic status in patients on mechanical ventilation. Furthermore, in patients undergoing CRRT, electrolyte balance must be monitored every 4 hours. Therefore, the blood sample for the study inevitably coincides with one of the routine blood samples.\n\nThe test tube, labeled with a unique code, will be sent to the central laboratory, which will centrifuge the blood and extract the plasma. This aliquot will then be stored at -80°C in a dedicated space and sent to the designated laboratory upon analysis.\n\nDetermination of the plasma dosage of the antibiotic in use is commonly performed on patients admitted to the Intensive Care Unit, where clinically necessary. Participation in the study does not change current clinical practices.",[61],"Septic Shock",[63,64,65,66,67,68],"antibiotic","target drug monitoring","meropenem","linezolid","daptomycin","in vivo","2026-04-13",{"date":71,"type":72},"2026-04-15","ACTUAL",{"date":74,"type":72},"2025-01-15",{"date":76,"type":57},"2026-08-15",{"name":5,"class":6},1]