[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502075":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":41,"responsibleParty":241,"collaborators":25,"id":243,"slug":244,"hasResults":245,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":245,"sex":251,"minAge":252,"maxAge":25,"enrollmentInfo":253,"targetDuration":25,"studyType":256,"phases":257,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":279},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Corrective strategy","EXPERIMENTAL","In the experimental group, all patients will have a UFnet settled (2 ml\u002Fkg\u002Fh ) in order to reach the patient baseline body weight.",[13],"Procedure: Fluid balance negativation",{"label":15,"type":6,"description":16,"interventionNames":17},"Stabilizing strategy","In the control group, all patients will have a UFnet 2 ml settled (0 to 1 ml\u002Fkg\u002Fh) in order to stabilize the patient body weight.",[18],"Procedure: Body weight Stabilization",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Fluid balance negativation","During the RRT, UFnet will be settled on 2ml\u002Fkg\u002Fh and adapted to hemodynamic tolerance and tissue perfusion .\n\nWhen the patient's baseline body weight is reached the UF net will be settled to maintain it.\n\nIn case of failure of the fluid balance negativation after 24h, UFnet will be settled on 3ml\u002Fkg\u002Fh. Then when the baseline body weight is reached UFnet will be settled on 0.5 et 1ml\u002Fkg\u002Fh or if necessary adapted to 1,5ml\u002Fkg\u002Fh to maintain it\n\nIn case of hemodynamic intolerance (NADN \\> 0,5 µg\u002Fkg\u002Fmin) or tissue hypoperfusion, UF net will be stopped during 6 hours and restarted if NADN \\\u003C 0,5 µg\u002Fkg\u002Fmin and without tissue hypoperfusion.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Body weight Stabilization","During the RRT, UFnet will be settled between 0 et 1 ml\u002Fkg\u002Fh and adapted in case of weight stabilization failure or hemodynamic intolerance.\n\nIn case of weight stabilisation failure ( variation \\>3% after 24h), the UF net can be increased to 1,5 ml\u002Fkg\u002Fh, as long as high intakes require UFnette at 1.5mL\u002Fkg\u002Fh to stabilize water balance, with daily reassessment.\n\nIn case of hemodynamic intolerance (NADN \\> 0,5 µg\u002Fkg\u002Fmin), UF net will be stopped during 6 hours and restarted if NADN \\\u003C 0,5 µg\u002Fkg\u002Fmin.",[15],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Matthias JACQUET LAGREZE, MD PhD","CONTACT","04 72 35 79 41","+33","Matthias.jacquet-lagreze@chu-lyon.fr",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Julia CANTERINI, project manager","04 27 85 66 28","Julia.canterini@chu-lyon.fr",[42,63,78,91,106,120,135,150,165,177,188,200,212,226],{"facility":43,"status":44,"city":45,"state":25,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Centre Hospitalier d'Ajaccio","NOT_YET_RECRUITING","Ajaccio","20090","France","FR",{"type":50,"coordinates":51},"Point",[52,53],8.73812,41.91886,{"lat":53,"lon":52},[56,60],{"name":57,"role":33,"phone":58,"phoneExt":35,"email":59},"Marie Geniez, Md","04 95 29 91 25","marie.geniez@ch-ajaccio.fr",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"Marie Geniez, MD","PRINCIPAL_INVESTIGATOR",{"facility":64,"status":44,"city":65,"state":25,"zip":66,"country":47,"countryCode":48,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"CHU Amiens-Picardie","Amiens","80480",{"type":50,"coordinates":68},[69,70],2.3,49.9,{"lat":70,"lon":69},[73,77],{"name":74,"role":33,"phone":75,"phoneExt":35,"email":76},"Osama ABOU ARAB, Pr","03 22 08 78 36","abouarab.osama@chu-amiens.fr",{"name":74,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":79,"status":80,"city":81,"state":25,"zip":82,"country":47,"countryCode":48,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Service d'Anesthesie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon","RECRUITING","Bron","69500",{"type":50,"coordinates":84},[85,86],4.91303,45.73865,{"lat":86,"lon":85},[89],{"name":90,"role":33,"phone":34,"phoneExt":35,"email":36},"Matthias JACQUET LAGREZE, MD",{"facility":92,"status":44,"city":93,"state":25,"zip":94,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"CHU Caen Normandie","Caen","14033",{"type":50,"coordinates":96},[97,98],-0.35912,49.18585,{"lat":98,"lon":97},[101,105],{"name":102,"role":33,"phone":103,"phoneExt":35,"email":104},"Sébastien DERVILLE, Dr","02 31 06 47 36","derville-s@chu-caen.fr",{"name":102,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":107,"status":80,"city":108,"state":25,"zip":109,"country":47,"countryCode":48,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Service de Réanimation, CHU de Dijon","Dijon","21000",{"type":50,"coordinates":111},[112,113],5.01391,47.31344,{"lat":113,"lon":112},[116],{"name":117,"role":33,"phone":118,"phoneExt":35,"email":119},"Pierre-Grégoire GUINOT, MD","03 80 29 56 03","pierregregoire.guinot@chu-dijon.fr",{"facility":121,"status":44,"city":122,"state":25,"zip":123,"country":47,"countryCode":48,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"GHP Saint Joseph Marie Lannelongue","Le Plessis-Robinson","92350",{"type":50,"coordinates":125},[126,127],2.27078,48.78889,{"lat":127,"lon":126},[130,134],{"name":131,"role":33,"phone":132,"phoneExt":35,"email":133},"Thibaut GENTY, Dr","01 40 94 22 60","t.genty@ghpsj.fr",{"name":131,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":136,"status":44,"city":137,"state":25,"zip":138,"country":47,"countryCode":48,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"CHU Lille - Hôpital Roger Salengro","Lille","59037",{"type":50,"coordinates":140},[141,142],3.05512,50.63391,{"lat":142,"lon":141},[145,149],{"name":146,"role":33,"phone":147,"phoneExt":35,"email":148},"Laurent ROBRIQUET, Dr","03 20 44 40 84","Laurent.ROBRIQUET@chu-lille.fr",{"name":146,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":151,"status":80,"city":152,"state":25,"zip":153,"country":47,"countryCode":48,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Hôpital Edouard Herriot, Groupement Hospitalier Centre","Lyon","69003",{"type":50,"coordinates":155},[156,157],4.84789,45.74906,{"lat":157,"lon":156},[160,164],{"name":161,"role":33,"phone":162,"phoneExt":35,"email":163},"Frank Bidar, MD","0472116942","frank.bidar@chu-lyon.fr",{"name":161,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":166,"status":44,"city":152,"state":25,"zip":167,"country":47,"countryCode":48,"cosmosGeoPoint":168,"geoPoint":170,"contacts":171},"Hôpital de la Croix Rousse","69004",{"type":50,"coordinates":169},[156,157],{"lat":157,"lon":156},[172,176],{"name":173,"role":33,"phone":174,"phoneExt":35,"email":175},"Laurent Bitker, MD","04 26 10 92 69","laurent.bitker@chu-lyon.fr",{"name":173,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":166,"status":80,"city":152,"state":25,"zip":167,"country":47,"countryCode":48,"cosmosGeoPoint":178,"geoPoint":180,"contacts":181},{"type":50,"coordinates":179},[156,157],{"lat":157,"lon":156},[182,187],{"name":183,"role":33,"phone":184,"phoneExt":185,"email":186},"Marie-Charlotte Delignette, MD","04 72 11 89 47","33","marie-charlotte.delignette@chu-lyon.fr",{"name":183,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":189,"status":80,"city":152,"state":25,"zip":190,"country":47,"countryCode":48,"cosmosGeoPoint":191,"geoPoint":193,"contacts":194},"Service de Réanimation, Clinique de la Sauvegarde","69009",{"type":50,"coordinates":192},[156,157],{"lat":157,"lon":156},[195,199],{"name":196,"role":33,"phone":197,"phoneExt":35,"email":198},"Guillaume Boulay, MD","04 78 64 06 50","guillaumeboulay85@gmail.com",{"name":196,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":201,"status":44,"city":152,"state":25,"zip":202,"country":47,"countryCode":48,"cosmosGeoPoint":203,"geoPoint":205,"contacts":206},"Hôpital Edouard Herriot","69437",{"type":50,"coordinates":204},[156,157],{"lat":157,"lon":156},[207,211],{"name":208,"role":33,"phone":209,"phoneExt":185,"email":210},"Martin COUR, MD","04 72 11 28 62","martin.cour@chu-lyon.fr",{"name":208,"role":62,"phone":25,"phoneExt":25,"email":25},{"facility":213,"status":80,"city":214,"state":25,"zip":215,"country":47,"countryCode":48,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Département d'anesthésie réanimation Hôpital Européen Georges Pompidou","Paris","75015",{"type":50,"coordinates":217},[218,219],2.3488,48.85341,{"lat":219,"lon":218},[222],{"name":223,"role":33,"phone":224,"phoneExt":35,"email":225},"Nicolas POLGE, MD","01 56 09 34 25","nicolas.polge@aphp.fr",{"facility":227,"status":44,"city":228,"state":25,"zip":229,"country":47,"countryCode":48,"cosmosGeoPoint":230,"geoPoint":234,"contacts":235},"Hôpitaux de Bradois - CHRU Nancy","Vandœuvre-lès-Nancy","54511",{"type":50,"coordinates":231},[232,233],6.17114,48.66115,{"lat":233,"lon":232},[236,240],{"name":237,"role":33,"phone":238,"phoneExt":35,"email":239},"Philippe GUERCY, Professor","03 83 15 79 95","P.GUERCI@chru-nancy.fr",{"name":237,"role":62,"phone":25,"phoneExt":25,"email":25},{"type":242,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100502075","early-deresuscitation-strategy-driven-by-tissue-perfusion-in-renal-replacement-therapy-in-patients-with-acute-renal-failure-100502075",false,"NCT05817539","Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure","Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure in Intensive Care Unit. A Randomized Study","EarlyDry","Inclusion Criteria:\n\n1. Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,\n2. At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or oxygen therapy or vascular filling \\> 1000ml or vasopressor exposure \\> 12 hours),\n3. Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion,\n4. Norepinephrine \\\u003C 0,5 µg\u002Fkg\u002Fmin,\n5. Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria:\n\n   * TRC \\> 3s at the finger\n   * Marbrure score \\> 2\n   * Lactate \\> 2 mmol\u002FL\n   * ScVO2\\\u003C 60%,\n6. Fluid overload defined as follows :\n\n   * fluid overload \\> 5% of base weight (based on cumulative fluid balance or a weight gain) and\u002For\n   * Obvious oedema of the lumbar region or flanks (oedema \\> 1cm bucket depth).\n\nExclusion Criteria:\n\n1. Chronic renal failure hemodialyzed before admission to the ICU,\n2. Mechanical circulatory support (ECMO, LVAD),\n3. Pregnant, child -bearing age or lactating women,\n4. Stroke based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less than 30 days,\n5. Intestinal ischemia less than 7 days documented non-operated,\n6. Interventional study participation or exclusion period on going,that may interfere with the present study\n7. Guardianship, curatorship or safeguard of justice,\n8. Absence of signature of free and informed consent by the patient and\u002For relative,\n9. Patients not affiliated to a social security scheme or beneficiaries of a similar scheme","ALL","18 Years",{"count":254,"type":255},250,"ESTIMATED","INTERVENTIONAL",[258],"NA","In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality.\n\nPatients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions.\n\nIn usual practice, UF net prescription are variable and there are different international recommendations. Some observational studies suggest that using a UFnet between 1 et 1.75 mL\u002Fkg\u002Fh in fluid overloaded patient decrease mortality.\n\nFluid overload increases morbidity and mortality, particularly in RRT. Studies without RRT argue for an efficacy of management by decreasing the fluid overload .Cohort studies suggest to use a moderate UFnet instead of a low UFnet. Some data from studies on early versus late RRT that relate the fluid balance or correct the fluid overload during the early strategy argue for a beneficial effect of an early deresuscitation strategy\n\nConsequently, the impact of a moderate UFnet (to decrease the fluid overload) compared to a low UFnet (to stabilize the fluid overload) in a randomized interventional study could be assessed.\n\nThe study hypothesis is that :\n\nan early fluid overload deresuscitation protocol with a high UFnet (2 ml\u002Fkg\u002Fh) targeting both the negativation of cumulated fluid balance to reach a dry weight and the maintenance of tissue perfusion.\n\nCompared to\n\nfluid overload deresuscitation protocol with a low UFnet (between 0 and 1 ml\u002Fkg\u002Fh) to reach a stabilization of cumulated fluid balance without monitoring the tissue perfusion.\n\ncould improve overall, renal, hemodynamic and respiratory prognosis in fluid overloaded patients with renal replacement therapy in ICU",[261,262],"Acute Kidney Injury","Fluid Overload",[264,265,266,267,268,269],"Renal Replacement Therapy (RRT)","Ultrafiltration","Deresuscitation","Fluid balance","Fluid overload","Tissue perfusion","2026-01-07",{"date":272,"type":273},"2026-01-08","ACTUAL",{"date":275,"type":273},"2023-12-15",{"date":277,"type":255},"2028-01-15",{"name":5,"class":6},14]