[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100376352":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":46,"studyPopulation":34,"armGroups":47,"interventions":60,"overallOfficials":71,"centralContacts":76,"locations":85,"responsibleParty":409,"collaborators":413,"id":420,"slug":421,"hasResults":422,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":422,"sex":428,"minAge":429,"maxAge":34,"enrollmentInfo":430,"targetDuration":34,"studyType":433,"phases":434,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":88,"whyStopped":34,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},{"fullName":5,"class":6},"Nordsjaellands Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":12,"otherOutcomes":34},[9],{"measure":10,"description":10,"timeFrame":11},"Days alive and out of hospital","90 days after randomization",[13,15,18,21,25,29,32],{"measure":14,"description":14,"timeFrame":11},"All cause mortality",{"measure":16,"description":17,"timeFrame":11},"Mortality and life support","Days alive without life support without life support (vasopressor\u002Finotropic support, invasive mechanical ventilation or renal replacement therapy)",{"measure":19,"description":14,"timeFrame":20},"Mortality 1 year","one year after randomization",{"measure":22,"description":23,"timeFrame":24},"Serious adverse events and reactions","Number of participants with one or more serious adverse events and serious adverse reactions","90 days",{"measure":26,"description":27,"timeFrame":28},"Health related quality of life","Measured using the European quality of Life 5D-5L questionnaire (5D-5L is the full name of the questionnaire). Index value of 1 represents full health and dead = 0. These value sets reflect the preferences of the general population. The European quality of life visual analogue scale is a self-reported assessment of the participant's health status. Scores on 100 = the best health you can imagine and 0 = the worst health you can imagine.","1 year after randomization",{"measure":30,"description":31,"timeFrame":28},"Cognitive function","Cognitive function assessed by the Montreal Cognitive Assessment score. Using the mini test for telephone interview. The test and scoring system will soon be published from Montreal Cognitive Assessment.",{"measure":26,"description":33,"timeFrame":28},"Subjective assessment (unacceptable, neutral, acceptable)",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":41},"QUADRUPLE",[42,43,44,45],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Furosemide","ACTIVE_COMPARATOR","Bolus of 5-40 mg (0.5 - 4 ml) of furosemide iv at physicians discretion followed by infusion of furosemide. Infusion rate: 0-40 mg\u002Fhour. Starting rate: 20 mg\u002Fhour. The infusion is adjusted according effect. Target is a negative fluid balance of 1 ml\u002Fkg\u002Fhour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.",[53],"Drug: Furosemide",{"label":55,"type":56,"description":57,"interventionNames":58},"Placebo","PLACEBO_COMPARATOR","Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 0.5-4 ml at physicians discretion. Infusion rate: 0 - 4 ml\u002Fhour. Infusion is started at 2 ml\u002Fhour and adjusted according to effect. Target is a negative fluid balance of 1 ml\u002Fkg\u002Fhour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.",[59],"Drug: Isotonic saline",[61,67],{"type":62,"name":49,"description":63,"armGroupLabels":64,"otherNames":65},"DRUG","Furosemide 10 mg\u002Fml for injection\u002Finfusion",[49],[66],"Furix",{"type":62,"name":68,"description":69,"armGroupLabels":70,"otherNames":34},"Isotonic saline","Isotonic saline used as placebo (injection\u002Finfusion)",[55],[72],{"name":73,"affiliation":74,"role":75},"Morten Bestle, MD","Department of Anaesthesiology and Intensive Care medicine Nordsjællands hospital","STUDY_CHAIR",[77,82],{"name":78,"role":79,"phone":80,"phoneExt":34,"email":81},"Sine Wichmann, MD","CONTACT","+45 26142620","sine.wichmann@regionh.dk",{"name":73,"role":79,"phone":83,"phoneExt":34,"email":84},"+45 41951195","morten.bestle@regionh.dk",[86,102,110,123,134,145,156,168,176,188,196,208,220,231,242,254,266,277,289,300,309,321,332,339,349,362,375,385,394],{"facility":87,"status":88,"city":89,"state":34,"zip":34,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":98},"Department of Intensive Care, Liverpool Hospital","RECRUITING","Sydney","Australia","AU",{"type":93,"coordinates":94},"Point",[95,96],151.20732,-33.86785,{"lat":96,"lon":95},[99],{"name":100,"role":101,"phone":34,"phoneExt":34,"email":34},"Anders Aneman, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":103,"status":88,"city":89,"state":34,"zip":34,"country":90,"countryCode":91,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Department of Intensive Care, Royal North Shore Hospital",{"type":93,"coordinates":105},[95,96],{"lat":96,"lon":95},[108],{"name":109,"role":101,"phone":34,"phoneExt":34,"email":34},"Anthony Delaney, Ass. professor",{"facility":111,"status":112,"city":113,"state":34,"zip":34,"country":114,"countryCode":34,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Department of Intensive Care, University Hospital of Ostrava","NOT_YET_RECRUITING","Ostrava","Czechia",{"type":93,"coordinates":116},[117,118],18.28204,49.83465,{"lat":118,"lon":117},[121],{"name":122,"role":101,"phone":34,"phoneExt":34,"email":34},"Jan Máca, MD, PhD",{"facility":124,"status":88,"city":125,"state":34,"zip":34,"country":114,"countryCode":34,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Department of Intensive Care, University Hospital of Pilsen","Pilsen",{"type":93,"coordinates":127},[128,129],13.37759,49.74747,{"lat":129,"lon":128},[132],{"name":133,"role":101,"phone":34,"phoneExt":34,"email":34},"Marek Nalos, MD, PhD",{"facility":135,"status":88,"city":136,"state":34,"zip":34,"country":114,"countryCode":34,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Department of Intensive Care, IKEM","Prague",{"type":93,"coordinates":138},[139,140],14.42076,50.08804,{"lat":140,"lon":139},[143],{"name":144,"role":101,"phone":34,"phoneExt":34,"email":34},"Petr Piza, MD",{"facility":146,"status":147,"city":148,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":34},"Department of Intensive Care, Sygehus Sønderjylland Aabenraa","TERMINATED","Aabenraa","Denmark","DK",{"type":93,"coordinates":152},[153,154],9.41741,55.04434,{"lat":154,"lon":153},{"facility":157,"status":88,"city":158,"state":34,"zip":159,"country":149,"countryCode":150,"cosmosGeoPoint":160,"geoPoint":164,"contacts":165},"Departmen of Intensive Care","Aalborg","9000",{"type":93,"coordinates":161},[162,163],9.9187,57.048,{"lat":163,"lon":162},[166],{"name":167,"role":101,"phone":34,"phoneExt":34,"email":34},"Meike T Behazadi, MD",{"facility":169,"status":147,"city":170,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":171,"geoPoint":175,"contacts":34},"Department of Intensive Care, Aarhus University Hospital","Aarhus",{"type":93,"coordinates":172},[173,174],10.21076,56.15674,{"lat":174,"lon":173},{"facility":177,"status":88,"city":178,"state":34,"zip":179,"country":149,"countryCode":150,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Department of Intensive Care, Rigshospitalet","Copenhagen","2100",{"type":93,"coordinates":181},[182,183],12.56553,55.67594,{"lat":183,"lon":182},[186],{"name":187,"role":101,"phone":34,"phoneExt":34,"email":34},"Anders Bastiansen, MD",{"facility":189,"status":147,"city":190,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":191,"geoPoint":195,"contacts":34},"Departement of Intensive Care, Gentofte Hospital","Gentofte Municipality",{"type":93,"coordinates":192},[193,194],12.54601,55.74903,{"lat":194,"lon":193},{"facility":197,"status":88,"city":198,"state":34,"zip":199,"country":149,"countryCode":150,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Department of Intensive Care, Herlev Hospital","Herlev","2730",{"type":93,"coordinates":201},[202,203],12.43998,55.72366,{"lat":203,"lon":202},[206],{"name":207,"role":101,"phone":34,"phoneExt":34,"email":34},"Anne Sofie Andreasen, MD, PhD",{"facility":209,"status":88,"city":210,"state":34,"zip":211,"country":149,"countryCode":150,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Department of Intensive Care, Regionshospital Gødstrup","Herning","7400",{"type":93,"coordinates":213},[214,215],8.97662,56.13615,{"lat":215,"lon":214},[218],{"name":219,"role":101,"phone":34,"phoneExt":34,"email":34},"Thomas Troelsen, MD",{"facility":221,"status":88,"city":222,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Department of Intensive Care, Nordsjællands hospital","Hillerød",{"type":93,"coordinates":224},[225,226],12.30081,55.92791,{"lat":226,"lon":225},[229],{"name":230,"role":101,"phone":34,"phoneExt":34,"email":34},"Sine Wichmann, MD, PhD, Ass. professor",{"facility":232,"status":88,"city":233,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Department of Intensive Care, Regionshospital Nordjylland Hjørring","Hjørring",{"type":93,"coordinates":235},[236,237],9.98229,57.46417,{"lat":237,"lon":236},[240],{"name":241,"role":101,"phone":34,"phoneExt":34,"email":34},"Kjeld Damgaard, MD, PhD",{"facility":243,"status":88,"city":244,"state":34,"zip":245,"country":149,"countryCode":150,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"Department of Intensive Care","Kolding","6000",{"type":93,"coordinates":247},[248,249],9.47216,55.4904,{"lat":249,"lon":248},[252],{"name":253,"role":101,"phone":34,"phoneExt":34,"email":34},"Anne C Brøchner, MD, PhD",{"facility":255,"status":88,"city":256,"state":34,"zip":257,"country":149,"countryCode":150,"cosmosGeoPoint":258,"geoPoint":262,"contacts":263},"Department of Intensive Care, Zealand University hospital","Køge","4600",{"type":93,"coordinates":259},[260,261],12.18214,55.45802,{"lat":261,"lon":260},[264],{"name":265,"role":101,"phone":34,"phoneExt":34,"email":34},"Lars Nebrich, MD",{"facility":243,"status":88,"city":267,"state":34,"zip":268,"country":149,"countryCode":150,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"Odense","5000",{"type":93,"coordinates":270},[271,272],10.38831,55.39594,{"lat":272,"lon":271},[275],{"name":276,"role":101,"phone":34,"phoneExt":34,"email":34},"Louise G Nielsen, MD",{"facility":278,"status":88,"city":279,"state":34,"zip":280,"country":149,"countryCode":150,"cosmosGeoPoint":281,"geoPoint":285,"contacts":286},"Department of Intensive Care, Regionshospitalet Randers","Randers","8930",{"type":93,"coordinates":282},[283,284],10.03639,56.4607,{"lat":284,"lon":283},[287],{"name":288,"role":101,"phone":34,"phoneExt":34,"email":34},"Marianne Vang, MD",{"facility":290,"status":88,"city":291,"state":34,"zip":34,"country":149,"countryCode":150,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Department of Intensive Care, University Hospital Zealand, Roskilde","Roskilde",{"type":93,"coordinates":293},[294,295],12.08035,55.64152,{"lat":295,"lon":294},[298],{"name":299,"role":101,"phone":34,"phoneExt":34,"email":34},"Thomas Hildebrandt, MD",{"facility":243,"status":301,"city":302,"state":34,"zip":303,"country":149,"countryCode":150,"cosmosGeoPoint":304,"geoPoint":308,"contacts":34},"WITHDRAWN","Vejle","7100",{"type":93,"coordinates":305},[306,307],9.5357,55.70927,{"lat":307,"lon":306},{"facility":310,"status":88,"city":311,"state":34,"zip":312,"country":149,"countryCode":150,"cosmosGeoPoint":313,"geoPoint":317,"contacts":318},"Regionshospitalet Viborg","Viborg","8800",{"type":93,"coordinates":314},[315,316],9.40201,56.45319,{"lat":316,"lon":315},[319],{"name":320,"role":101,"phone":34,"phoneExt":34,"email":34},"Christoffer Grant Sølling, MD, PhD",{"facility":322,"status":147,"city":323,"state":34,"zip":324,"country":325,"countryCode":326,"cosmosGeoPoint":327,"geoPoint":331,"contacts":34},"Department of Intensive Care, Tampere University Hospital","Tampere","33520","Finland","FI",{"type":93,"coordinates":328},[329,330],23.78712,61.49911,{"lat":330,"lon":329},{"facility":243,"status":147,"city":333,"state":34,"zip":34,"country":325,"countryCode":326,"cosmosGeoPoint":334,"geoPoint":338,"contacts":34},"Turku",{"type":93,"coordinates":335},[336,337],22.26869,60.45148,{"lat":337,"lon":336},{"facility":340,"status":147,"city":341,"state":34,"zip":34,"country":342,"countryCode":343,"cosmosGeoPoint":344,"geoPoint":348,"contacts":34},"Department of Intensive Care, Landspitali National University Hospital of Iceland","Reykjavik","Iceland","IS",{"type":93,"coordinates":345},[346,347],-21.89541,64.13548,{"lat":347,"lon":346},{"facility":350,"status":88,"city":351,"state":34,"zip":34,"country":352,"countryCode":353,"cosmosGeoPoint":354,"geoPoint":358,"contacts":359},"Vilnius University Hospital Santaros Clinics","Vilnius","Lithuania","LT",{"type":93,"coordinates":355},[356,357],25.2798,54.68916,{"lat":357,"lon":356},[360],{"name":361,"role":101,"phone":34,"phoneExt":34,"email":34},"Ieva Jovaišienė, Professor",{"facility":363,"status":88,"city":364,"state":34,"zip":34,"country":365,"countryCode":366,"cosmosGeoPoint":367,"geoPoint":371,"contacts":372},"Department of Critical Care, University Medical Center Groningen","Groningen","Netherlands","NL",{"type":93,"coordinates":368},[369,370],6.56667,53.21917,{"lat":370,"lon":369},[373],{"name":374,"role":101,"phone":34,"phoneExt":34,"email":34},"Eric Keus, MD",{"facility":376,"status":147,"city":377,"state":34,"zip":34,"country":378,"countryCode":379,"cosmosGeoPoint":380,"geoPoint":384,"contacts":34},"Department of Intensive Care, Ålesund Sjukehus","Ålesund","Norway","NO",{"type":93,"coordinates":381},[382,383],6.15492,62.47225,{"lat":383,"lon":382},{"facility":386,"status":147,"city":387,"state":34,"zip":388,"country":378,"countryCode":379,"cosmosGeoPoint":389,"geoPoint":393,"contacts":34},"Department of Intensive Care, Stavanger University Hospital","Stavanger","4068",{"type":93,"coordinates":390},[391,392],5.73332,58.97005,{"lat":392,"lon":391},{"facility":395,"status":88,"city":396,"state":34,"zip":34,"country":397,"countryCode":398,"cosmosGeoPoint":399,"geoPoint":403,"contacts":404},"Department of Intensive Care, Inselspital","Bern","Switzerland","CH",{"type":93,"coordinates":400},[401,402],7.44744,46.94809,{"lat":402,"lon":401},[405,407],{"name":406,"role":79,"phone":34,"phoneExt":34,"email":34},"Carmen Pfortmueller, MD, PhD",{"name":408,"role":101,"phone":34,"phoneExt":34,"email":34},"Jan Waskowski, MD, PhD",{"type":410,"investigatorFullName":411,"investigatorTitle":412,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Morten H. Bestle","Senior staff specialist and Professor",[414,416,418],{"name":415,"class":6},"University of Copenhagen",{"name":417,"class":6},"Copenhagen Trial Unit, Center for Clinical Intervention Research",{"name":419,"class":6},"Centre for Research in Intensive Care (CRIC)","100376352","phase-4-controlled-fluid-removal-in-critical-ill-patients-with-fluid-overload-in-the-intensive-care-unit-100376352",false,"NCT04180397","Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit.","Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).","GODIF","Inclusion Criteria: ALL below must be met.\n\n* Acute admission to the intensive care unit.\n* Age ≥ 18 years of age\n* Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.\n* Clinical stable (minimum criteria: MAP \\> 50 mmHg and maximum infusion of 20 microgram\u002Fkg\u002Fminute of noradrenaline and lactate \\\u003C 4.0 mmol\u002FL)\n\nExclusion Criteria:\n\n* Known allergy to furosemide or sulphonamides.\n* Known pre-hospitalization advanced chronic kidney disease (eGFR \\\u003C 30 mL\u002Fminute\u002F1.73 m\\^2 or chronic RRT).\n* Ongoing renal replacement therapy.\n* Anuria \\> 6 hours.\n* Rhabdomyolysis with indication for forced diuresis\n* Ongoing life-threatening bleeding as these patients need specific fluid\u002Fblood product strategies.\n* Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy.\n* Severe dysnatremia (p-Na \\\u003C 120 or \\> 155 mmol\u002FL) as these patients need a specific fluid strategy.\n* Severe hepatic failure as per the clinical team.\n* Patients undergoing forced treatment.\n* Fertile women (women \\\u003C 50 years) with positive urine human chorionic gonadotropin (hCG) or plasma-hCG.\n* Consent not obtainable as per the model approved for the specific trial site.","ALL","18 Years",{"count":431,"type":432},1000,"ESTIMATED","INTERVENTIONAL",[435],"PHASE4","This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.",[438],"Fluid Overload",[440,441,442,443,444],"Fluid overload","Fluid removal","Deresusciation","Diuretics","Fluid accumulation","2026-06-02",{"date":447,"type":448},"2026-06-03","ACTUAL",{"date":450,"type":448},"2020-08-17",{"date":452,"type":432},"2028-04-15",{"name":411,"class":6},29]