[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100311048":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":40,"locations":50,"responsibleParty":66,"collaborators":68,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":68,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":53,"whyStopped":68,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University Hospital, Montpellier","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low sodium concentration","ACTIVE_COMPARATOR","Concentration of sodium in dialysate at 140 mmol\u002Fl ( Lowering sodium concentration dialysate)",[13],"Drug: Lowering sodium concentration dialysate",{"label":15,"type":16,"description":17,"interventionNames":18},"High Sodium Concentration","SHAM_COMPARATOR","Concentration of sodium in dialysate at 145 mmol\u002Fl (Highing sodium concentration dialysate)",[19],"Drug: Highing sodium concentration dialysate",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lowering sodium concentration dialysate","Concentration of sodium in dialysate at 140 mmol\u002Fl",[9],[24],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Highing sodium concentration dialysate","Concentration of sodium in dialysate at 145 mmol\u002Fl",[15],[29],[33,36],{"name":34,"affiliation":5,"role":35},"vincent BRUNOT, MD","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"aurèle BUZANCAIS, MD","UHNIMES","STUDY_DIRECTOR",[41,46],{"name":34,"role":42,"phone":43,"phoneExt":44,"email":45},"CONTACT","467332495","33","v-brunot@chu-montpellier.fr",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"kada KLOUCHE, MD, PhD","467338441","k-klouche@chu-montpellier.fr",[51],{"facility":52,"status":53,"city":54,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Uhmontpellier","RECRUITING","Montpellier","34295","France","FR",{"type":59,"coordinates":60},"Point",[61,62],3.87635,43.61093,{"lat":62,"lon":61},[65],{"name":34,"role":42,"phone":43,"phoneExt":44,"email":45},{"type":67,"investigatorFullName":68,"investigatorTitle":68,"investigatorAffiliation":68,"oldNameTitle":68,"oldOrganization":68},"SPONSOR",null,"100311048","phase-2-effects-of-variation-of-sodium-dialysate-in-icu-100311048",false,"NCT03329313","Effects of Variation of Sodium Dialysate in ICU","Effects of Variation of Sodium Dialysate in ICU Acute Kiney Injury","NADIRA","Inclusion criteria:\n\n* Age \\> 18 years old\n* Acute kidney injury requiring renal replacement therapy\n* Dialysis type: on line sustained low efficiency dialy dialysis -filtration\n* SOFA score \\> 5\n* Sodium serum level between 135 and 145mmol\u002Fl\n\nExclusion criteria:\n\n* Chronic kidney disease stade IV ou V\n* Obstrutive acute kidney injury\n* Renal tansplantation in the year before ICU admission\n* Moribund with risk of death in the 48 hours\n* Vulnerable persons or protected persons\n* Pregnant or breastfeeding mother","ALL","18 Years","80 Years",{"count":81,"type":82},158,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Intermittent hemodialysis\u002Fdiafiltration is a current renal replacement therapy (RRT) institued for ICU patients with AKI. For a better clinical tolerance, iinternational guidelines advise to use cold dialysate, increase duration session, decrease blood and dialysate flows, and increase level of sodium dialysate concentration (≥ 145mmol\u002Fl). Indeed, the use of a Na concentration dialysate \\> 145 mmol\u002Fl improves intradialytic hemodynamic tolerance but it may also induce fluid overload by the transfert of sodium from the dialysate compartment to the blood. Yet, fluid overload has been strongly associated with mortality in critically ills. The investigators hypothesized that the use of a level in sodium dialysate at 140 mmol\u002Fl with slow low efficiency daily dialysis-filtration (SLEDD-f) will permit a fair intradialytic hemodynamic tolerance without the adverse effect of intradiaclytic Na loading from the dialysate. Two randomized groups of ICU AKI patients treated by SLEDD-f will be compared in terms of intradialytic hemodynamic tolerance and overload accordong to 140 or 145 mmol\u002Fl of Na in the dialysate",[88,89],"Acute Kidney Injury","Renal Replacement Therapy",[91,92,93],"Intensive care unit","SLEDD-f","intermittent hemodialysis\u002Fdiafiltration","2025-09-24",{"date":96,"type":97},"2025-09-30","ACTUAL",{"date":99,"type":97},"2018-04-19",{"date":101,"type":82},"2026-12-19",{"name":5,"class":6},1]