[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611121":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":23,"centralContacts":27,"locations":35,"responsibleParty":61,"collaborators":22,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":22,"enrollmentInfo":73,"targetDuration":22,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":52,"whyStopped":22,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Sequence A: MEX-CD1-supplemented dialysate first, then standard dialysate","Participants will receive two consecutive 24-hour CVVHD sessions using:\n\n* Standard Dialysate: Commercially available CiCa™ dialysate (Fresenius Medical Care, Germany)\n* MEX-CD1 Dialysate: CiCa™ dialysate supplemented with MEX-CD1 at 50 mg\u002FL (28). MEX-CD1 remains confined to the dialysate, separated from the patient's circulation by the dialysis membrane because of its molecular weight",[12],"Combination Product: Continuous veino-veinous dialysis with iron-chelator supplemented dialysate",{"label":14,"type":6,"description":10,"interventionNames":15},"Sequence B: Standard dialysate first, then MEX-CD1-supplemented dialysate",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"COMBINATION_PRODUCT","Continuous veino-veinous dialysis with iron-chelator supplemented dialysate","Participants will receive two consecutive 24-hour CVVHD sessions using:\n\n* Standard Dialysate: Commercially available CiCa™ dialysate (Fresenius Medical Care, Germany)\n* MEX-CD1 Dialysate: CiCa™ dialysate supplemented with MEX-CD1 at 50 mg\u002FL (28). MEX-CD1 remains confined to the dialysate, separated from the patient's circulation by the dialysis membrane because of its molecular weight\n\nBoth sessions will use identical RRT parameters, no dose escalation is planned:\n\n* Continuous veno-venous hemodialysis (CVVHD) modality\n* Multifiltrate™ dialyzer (Fresenius Medical Care, Germany) with regional citrate anticoagulation\n* Dialysis dose of 20-25 mL\u002Fkg\u002Fh (approx. 1600 mL\u002Fh dialysate flow)\n* Blood flow 80 mL\u002Fmin\n* Ultrasound-guided placement of a 15 cm 16 F double-lumen catheter in the right internal jugular vein\n* The circuit and the dialysis filter will be changed after each 24 hours CVVHD session",[9,14],null,[24],{"name":25,"affiliation":5,"role":26},"Saber D BARBAR, MD, PhD","PRINCIPAL_INVESTIGATOR",[28,32],{"name":25,"role":29,"phone":30,"phoneExt":22,"email":31},"CONTACT","0033466683320","saber.barbar@chu-nimes.fr",{"name":33,"role":29,"phone":30,"phoneExt":22,"email":34},"Jean-Yves LEFRANT, MD, PhD","jean-yves.lefrant@chu-nimes.fr",[36,50],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":22},"Nimes University Hospital","NOT_YET_RECRUITING","Nîmes","Gard","30000","France","FR",{"type":45,"coordinates":46},"Point",[47,48],4.35788,43.83665,{"lat":48,"lon":47},{"facility":51,"status":52,"city":39,"state":22,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"CHU de Nîmes","RECRUITING","30029",{"type":45,"coordinates":55},[47,48],{"lat":48,"lon":47},[58],{"name":59,"role":29,"phone":60,"phoneExt":22,"email":31},"Saber BARBAR, PH","+ 33 4.66.68.33.20",{"type":62,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100611121","phase-1-labile-iron-removal-by-adding-the-iron-chelator-mex-cd1-to-dialysate-in-sepsis-associated-acute-kidney-injury-100611121",false,"NCT07236463","Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate in Sepsis-Associated Acute Kidney Injury","Performance and Safety of Labile Iron Removal by Adding the Iron Chelator MEX-CD1 to Dialysate During Continuous Veno-venous Hemodialysis for Sepsis-associated AKI: Protocol for a Phase I-II Randomized Crossover Pilot Study.","IRON-IC","Inclusion Criteria:\n\n* Adult patients (≥18 years) admitted to ICU with sepsis-associated AKI requiring CRRT\n* Sepsis defined according to SEPSIS-3 criteria (suspected\u002Fdocumented infection with organ dysfunction indicated by ≥2-point increase in SOFA \\[Sequential Organ Failure Assessment\\] score)\n* AKI Stage 3 per KDIGO (Kidney Disease: Improving Global Outcomes) criteria: acute rise in serum creatinine ≥3 times baseline or serum creatinine ≥4 mg\u002FdL or urine output \\\u003C0.3 mL\u002Fkg\u002Fh for ≥24 hours or anuria (urine output \\\u003C100ml) for ≥12 hours\n* Indications for CRRT: refractory hyperkalemia (\\>6 mmol\u002FL) or refractory metabolic acidosis (pH \\\u003C 7.20) or acute pulmonary edema unresponsive to medical management or urine output \\\u003C0.3 ml\u002Fkg\u002Fhour or anuria (urine output \\\u003C100ml) persistent for 48 hours and refractory to medical treatment\n* Informed consent obtained from patient or legal representative\n* Affiliated with or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* Known shellfish allergy\n* Moribund status with life expectancy too low to benefit\n* Concurrent participation in another interventional study\n* Exclusion period defined by another study\n* Under legal protection (guardianship or curatorship)\n* Inability to obtain informed consent from patient or representative\n* Pregnant, parturient, or breastfeeding women","ALL","18 Years",{"count":74,"type":75},14,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE1","PHASE2","The goal of this clinical trial is to learn if adding the iron-binding drug MEX-CD1 to dialysis fluid can help remove excess iron in adults with sepsis-associated acute kidney injury (AKI) requiring dialysis who are in the intensive care unit (ICU). The main questions it aims to answer are:\n\nDoes adding MEX-CD1 to the dialysis fluid increase the amount of iron removed during dialysis? Is using MEX-CD1 in dialysis fluid safe for patients?\n\nParticipants will:\n\nBe adults in the ICU with sepsis-associated AKI who need continuous dialysis (renal replacement therapy) Receive two 24-hour dialysis sessions: one with standard dialysis fluid and one with dialysis fluid containing MEX-CD1 Serve as their own control, meaning they will receive both treatments\n\nResearchers will measure:\n\nThe amount of iron removed in the dialysis waste fluid (primary outcome) Blood levels of iron Changes in other trace elements Markers of inflammation and oxidative stress Safety outcomes up to 28 days after treatment This is a pilot study being done at a single hospital in France.",[82,83],"Acute Kidney Injury","Sepsis",[82,83,85,86,87],"Continuous Renal Replacement Therapy","Iron Chelating Agents","Intensive Care Unit","2026-06-04",{"date":90,"type":91},"2026-06-05","ACTUAL",{"date":88,"type":91},{"date":94,"type":75},"2028-06",{"name":5,"class":6},2]