[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100526853":3},{"organization":4,"outcomesModule":7,"designInfo":71,"detailedDescription":74,"studyPopulation":74,"armGroups":83,"interventions":95,"overallOfficials":103,"centralContacts":107,"locations":115,"responsibleParty":298,"collaborators":74,"id":300,"slug":301,"hasResults":302,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":305,"eligibilityCriteria":306,"healthyVolunteers":302,"sex":307,"minAge":308,"maxAge":74,"enrollmentInfo":309,"targetDuration":74,"studyType":312,"phases":313,"briefSummary":315,"conditions":316,"keywords":318,"overallStatus":118,"whyStopped":74,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},{"fullName":5,"class":6},"Region Skane","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"Mortality","All-cause mortality","90 days after inclusion",[14,18,21,25],{"measure":15,"description":16,"timeFrame":17},"Complications in the ICU","Number of patients with one or more of the following complications in the ICU: cerebral, cardiac, intestinal or limb ischemia, or any acute kidney injury.","From inclusion until final discharge from ICU or death, whichever comes first, assessed up to 90 days",{"measure":19,"description":19,"timeFrame":20},"Mechanical ventilation-free days","Within 90 days after inclusion",{"measure":22,"description":23,"timeFrame":24},"Cognitive function","Cognitive function measured using the Montreal Cognitive Assessment (MoCA)","6 months after inclusion",{"measure":26,"description":27,"timeFrame":24},"Health-Related Quality of Life","Health-Related Quality of Life measured using the European Quality of Life visual analogue scale (EQ-VAS)",[29,31,33,36,39,43,46,48,51,54,56,59,62,65,68],{"measure":30,"description":30,"timeFrame":20},"Hospital-free days",{"measure":32,"description":32,"timeFrame":20},"Vasopressor-free days",{"measure":34,"description":35,"timeFrame":20},"Renal replacement therapy (RRT)-free days","RRT-free days",{"measure":37,"description":38,"timeFrame":12},"Major adverse kidney events (MAKE)","The composite of death, new receipt of renal replacement therapy, or persistent renal dysfunction (defined as a final inpatient creatinine value ≥200% of the baseline value)",{"measure":40,"description":41,"timeFrame":42},"Cumulative dose of diuretics","Cumulative dose of diuretics (defined daily doses according to the World Health Organization \\[WHO\\])","5 days after inclusion",{"measure":44,"description":45,"timeFrame":24},"Glasgow Outcome Scale Extended (GOSE) score","GOSE score",{"measure":26,"description":47,"timeFrame":24},"Health-Related Quality of Life measured using the European Quality of Life visual 5-dimension 5-level scale (EQ-5D-5L) questionnaire",{"measure":49,"description":50,"timeFrame":24},"Health and disability","Health and disability measured using the WHO Disability Assessment Schedule (WHODAS) 2.0 (12 item version)",{"measure":52,"description":53,"timeFrame":24},"Modified Fatigue Impact Scale (MFIS)","MFIS questionnaire (full-length version)",{"measure":10,"description":11,"timeFrame":55},"12 months after inclusion",{"measure":57,"description":57,"timeFrame":58},"Number of days in the ICU","Within 90 days of inclusion",{"measure":60,"description":61,"timeFrame":17},"Hypoglycaemia","Number of patients with moderate hypoglycaemia (glucose 3.9 - 2.3 mmol\u002Fl) and severe hypoglycaemia (glucose ≤ 2.2 mmol\u002Fl)",{"measure":63,"description":64,"timeFrame":17},"Hypernatremia","Number of patients with hypernatremia (sodium \\> 159 mmol\u002FL)",{"measure":66,"description":67,"timeFrame":17},"Acid-base disturbances","Number of patients with acid-base disturbances (hyperchloremic acidosis \\[pH \\\u003C 7.15 and plasma Cl- \\> 115\\] or metabolic alkalosis \\[pH \\> 7.59 and S-BE \\> 9\\])",{"measure":69,"description":70,"timeFrame":17},"Central venous catheter-related complications","Number of patients with any central venous catheter related complications that could potentially be related to concentrated drugs given in the intervention group (for example, thrombosis, stenosis, malfunction, and infections)",{"allocation":72,"interventionModel":73,"interventionModelDescription":74,"primaryPurpose":75,"observationalModel":74,"timePerspective":74,"maskingInfo":76},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":77,"maskingDescription":78,"whoMasked":79},"TRIPLE","The clinical team caring for participants will not be blinded due to the nature of the intervention. The participants and their family will not be actively informed about group allocation. The steering group, author group, trial statistician, outcome assessors, prognosticators, the trial coordinating team, manuscript writers and the data safety and monitoring committee will be blinded to group allocation.",[80,81,82],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR",[84,90],{"label":85,"type":86,"description":87,"interventionNames":88},"Protocolised reduction of non-resuscitation fluids","EXPERIMENTAL","Participants receive non-resuscitation fluids according to a pre-defined protocol starting within two hours of randomization. The intervention is continued for the duration of the ICU admission up to a maximum of 90 days.",[89],"Other: Protocolised reduction of non-resuscitation fluids",{"label":91,"type":6,"description":92,"interventionNames":93},"Usual Care","Participants receive non-resuscitation fluids according to local routines.",[94],"Other: Usual care",[96,99],{"type":6,"name":85,"description":97,"armGroupLabels":98,"otherNames":74},"Maintenance fluid: discontinued if cumulative fluid balance is positive and patient is not dehydrated Intravenous fluid and enteral water: as needed to correct electrolyte disturbances Enteral nutrition (at least 2 kcal\u002Fml): per local practice Glucose (conc. ≥20%, dose ≤1g\u002Fkg\u002Fday): may be used as nutrition if enteral feeding not tolerated starting 72h after inclusion. May be started earlier in patients with insulin-dependent diabetes or risk of hypoglycemia per local practice Parenteral nutrition: per local practice Intravenous medications: concentrated according to a predefined protocol Patients with neutral or negative cumulative fluid balance receive maintenance and other fluids so the total dose of fluids covers the daily need of water (about 1ml\u002Fkg\u002Fh)",[85],{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":74},"Usual care","Participants receive non-resuscitation fluids according to local routines, with the following stipulations:\n\nMaintenance fluids (crystalloids and\u002For glucose and\u002For enteral water): given at a dose of 1 ml\u002Fkg\u002Fh unless local protocol states otherwise Glucose: used at maximal concentration of 10% unless local protocol states otherwise.\n\nMedications: concentrated per local protocol",[91],[104],{"name":105,"affiliation":5,"role":106},"Peter Bentzer","PRINCIPAL_INVESTIGATOR",[108,112],{"name":105,"role":109,"phone":110,"phoneExt":74,"email":111},"CONTACT","+46 42-4061111","Peter.Bentzer@med.lu.se",{"name":113,"role":109,"phone":74,"phoneExt":74,"email":114},"Jane Fisher","jane.fisher@advansci-research.com",[116,128,137,145,153,163,171,179,187,192,200,208,216,224,232,240,248,256,264,272,280,288],{"facility":117,"status":118,"city":119,"state":74,"zip":74,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":74},"Helsinki University Hospital","RECRUITING","Helsinki","Finland","FI",{"type":123,"coordinates":124},"Point",[125,126],24.93545,60.16952,{"lat":126,"lon":125},{"facility":129,"status":130,"city":131,"state":74,"zip":74,"country":120,"countryCode":121,"cosmosGeoPoint":132,"geoPoint":136,"contacts":74},"Kuopio University Hospital","NOT_YET_RECRUITING","Kuopio",{"type":123,"coordinates":133},[134,135],27.67703,62.89238,{"lat":135,"lon":134},{"facility":138,"status":118,"city":139,"state":74,"zip":74,"country":120,"countryCode":121,"cosmosGeoPoint":140,"geoPoint":144,"contacts":74},"Tampere University Hospital","Tampere",{"type":123,"coordinates":141},[142,143],23.78712,61.49911,{"lat":143,"lon":142},{"facility":146,"status":130,"city":147,"state":74,"zip":74,"country":120,"countryCode":121,"cosmosGeoPoint":148,"geoPoint":152,"contacts":74},"Turku University Hospital","Turku",{"type":123,"coordinates":149},[150,151],22.26869,60.45148,{"lat":151,"lon":150},{"facility":154,"status":118,"city":155,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":162,"contacts":74},"Danderyd Hospital","Danderyd","Sweden","SE",{"type":123,"coordinates":159},[160,161],18.02376,59.40398,{"lat":161,"lon":160},{"facility":164,"status":118,"city":165,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":166,"geoPoint":170,"contacts":74},"Malar Hospital","Eskilstuna",{"type":123,"coordinates":167},[168,169],16.5077,59.36661,{"lat":169,"lon":168},{"facility":172,"status":118,"city":173,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":174,"geoPoint":178,"contacts":74},"Falun Hospital","Falun",{"type":123,"coordinates":175},[176,177],15.62597,60.60357,{"lat":177,"lon":176},{"facility":180,"status":118,"city":181,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":182,"geoPoint":186,"contacts":74},"Sahlgrenska University Hospital","Gothenburg",{"type":123,"coordinates":183},[184,185],11.96679,57.70716,{"lat":185,"lon":184},{"facility":188,"status":118,"city":181,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":189,"geoPoint":191,"contacts":74},"Östra Hospital",{"type":123,"coordinates":190},[184,185],{"lat":185,"lon":184},{"facility":193,"status":118,"city":194,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":195,"geoPoint":199,"contacts":74},"Halmstad Hospital","Halmstad",{"type":123,"coordinates":196},[197,198],12.85676,56.67446,{"lat":198,"lon":197},{"facility":201,"status":118,"city":202,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":203,"geoPoint":207,"contacts":74},"Helsingborg Hospital","Helsingborg",{"type":123,"coordinates":204},[205,206],12.69437,56.04673,{"lat":206,"lon":205},{"facility":209,"status":118,"city":210,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":211,"geoPoint":215,"contacts":74},"Skåne University Hospital, Lund","Lund",{"type":123,"coordinates":212},[213,214],13.19321,55.70584,{"lat":214,"lon":213},{"facility":217,"status":118,"city":218,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":219,"geoPoint":223,"contacts":74},"Skåne University Hospital, Malmö","Malmö",{"type":123,"coordinates":220},[221,222],13.00073,55.60587,{"lat":222,"lon":221},{"facility":225,"status":118,"city":226,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":227,"geoPoint":231,"contacts":74},"Norrtälje Hospital","Norrtälje",{"type":123,"coordinates":228},[229,230],18.70496,59.75799,{"lat":230,"lon":229},{"facility":233,"status":118,"city":234,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":235,"geoPoint":239,"contacts":74},"Örebro University Hospital","Örebro",{"type":123,"coordinates":236},[237,238],15.2066,59.27412,{"lat":238,"lon":237},{"facility":241,"status":118,"city":242,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":243,"geoPoint":247,"contacts":74},"Östersund Hospital","Östersund",{"type":123,"coordinates":244},[245,246],14.63566,63.1792,{"lat":246,"lon":245},{"facility":249,"status":118,"city":250,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":251,"geoPoint":255,"contacts":74},"Södertälje Hospital","Södertälje",{"type":123,"coordinates":252},[253,254],17.62525,59.19554,{"lat":254,"lon":253},{"facility":257,"status":118,"city":258,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":259,"geoPoint":263,"contacts":74},"Stockholm South General Hospital (SÖS)","Stockholm",{"type":123,"coordinates":260},[261,262],18.06871,59.32938,{"lat":262,"lon":261},{"facility":265,"status":118,"city":266,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":267,"geoPoint":271,"contacts":74},"University Hospital of Umeå","Umeå",{"type":123,"coordinates":268},[269,270],20.25972,63.82842,{"lat":270,"lon":269},{"facility":273,"status":118,"city":274,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":275,"geoPoint":279,"contacts":74},"Uppsala University Hospital","Uppsala",{"type":123,"coordinates":276},[277,278],17.63889,59.85882,{"lat":278,"lon":277},{"facility":281,"status":118,"city":282,"state":74,"zip":74,"country":156,"countryCode":157,"cosmosGeoPoint":283,"geoPoint":287,"contacts":74},"Varberg Hospital","Varberg",{"type":123,"coordinates":284},[285,286],12.25078,57.10557,{"lat":286,"lon":285},{"facility":289,"status":118,"city":290,"state":74,"zip":74,"country":291,"countryCode":292,"cosmosGeoPoint":293,"geoPoint":297,"contacts":74},"University Hospital of Wales","Cardiff","United Kingdom","UK",{"type":123,"coordinates":294},[295,296],-3.18,51.48,{"lat":296,"lon":295},{"type":299,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR","100526853","protocolized-reduction-of-non-resuscitation-fluids-versus-usual-care-in-septic-shock-patients-100526853",false,"NCT06140147","Protocolized Reduction of Non-resuscitation Fluids Versus Usual Care in Septic Shock Patients","REDUSE","Inclusion Criteria:\n\n* Adult (≥ 18 years of age)\n* Septic shock according to the Sepsis 3 criteria at any time within 12 hours after ICU admission (suspected or confirmed infection, plasma lactate above 2 mmol\u002FL, and infusion of vasopressor\u002Finotrope to maintain mean arterial pressure of 65mmHg or above after receiving adequate fluid resuscitation \\[\\> 1L within 12 h of screening\\]) and need for vasopressors at the time of screening.\n\nExclusion Criteria:\n\n* Confirmed or suspected pregnancy\n* Previous inclusion in the trial\n* Screened more than 12 hours after ICU admission","ALL","18 Years",{"count":310,"type":311},1850,"ESTIMATED","INTERVENTIONAL",[314],"NA","The objective of this trial is to assess the beneficial and harmful effects of a restrictive strategy for administration of non-resuscitation fluids in adult patients with septic shock.",[317],"Septic Shock",[319],"septic shock","2026-10-01",{"date":322,"type":323},"2026-10-06","ACTUAL",{"date":325,"type":323},"2023-11-27",{"date":327,"type":311},"2028-07-01",{"name":5,"class":6},22]