[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100461044":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":29,"locations":39,"responsibleParty":58,"collaborators":62,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":24,"enrollmentInfo":93,"targetDuration":24,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"IV-hydration group (standard of care according to international guidelines)","The IV-hydration with isotonic 0.9% NaCl will be initiated three hours prior to the IV CECT and completed four hours after IV CECT (infusion rate of 1-3 mL\u002Fkg\u002Fhour). Patients are prescribed a fixed volume of 1000 mL, which is equally distributed before and after IV CECT (500 mL before and 500 mL after).\n\nPatients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is also equally distributed before and after IV CECT (250 mL before and 250 mL after).",[12],"Other: Preventive treatment with IV-hydration",{"label":14,"type":15,"description":16,"interventionNames":17},"Oral hydration group","ACTIVE_COMPARATOR","The oral hydration regimen will be initiated one-two hours prior to IV CECT and completed within four hours after IV CECT. Patients are prescribed a fixed volume of 1000 mL, which is distributed equally before and after IV CECT (500 mL before and 500 mL after).\n\nPatients with heart failure (LVEF ≤ 40%) are prescribed a reduced volume of 500 mL, which is equally distributed before and after IV CECT (250 mL before and 250 mL after).",[18],"Other: Preventive treatment with oral hydration",[20,25],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Preventive treatment with IV-hydration","IV hydration with isotonic 0.9% NaCl",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Preventive treatment with oral hydration","Oral hydration with regular bottled water",[14],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Kristian Altern Øvrehus, Chief physician","CONTACT","+45 28305454","kristian.altern.ovrehus@rsyd.dk",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},"Emil Johannes Ravn, BSc.Med.","+45 31476794","emil.johannes.ravn2@rsyd.dk",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Cardiology","RECRUITING","Odense C","Fyn","5000","Denmark","DK",{"type":49,"coordinates":50},"Point",[51,52],10.39538,55.40841,{"lat":52,"lon":51},[55,57],{"name":56,"role":32,"phone":33,"phoneExt":24,"email":34},"Kristian Altern Øvrehus, Chief Physician",{"name":36,"role":32,"phone":37,"phoneExt":24,"email":38},{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Emil Johannes Ravn","Medical student and clinical research assistant",[63,66,68,70,72,74,76,79,81],{"name":64,"class":65},"Department of Nephrology, Odense University Hospital","UNKNOWN",{"name":67,"class":65},"Department of Clinical Genetics, Odense University Hospital",{"name":69,"class":65},"The A.P. Moller Foundation",{"name":71,"class":65},"The Research Counsil of Odense University Hospital",{"name":73,"class":65},"Copenhagen University's Research Foundation for Medical Students",{"name":75,"class":65},"Helen and Ejnar Bjørnow's Foundation",{"name":77,"class":78},"Novo Nordisk A\u002FS","INDUSTRY",{"name":80,"class":65},"Sophus Jacobsen and Astrid Jacobsen's Foundation",{"name":82,"class":6},"Region of Southern Denmark","100461044","intravenous-vs-oral-hydration-to-reduce-the-risk-of-post-contrast-acute-kidney-injury-after-intravenous-contrast-enhanced-computed-tomography-in-patients-with-severe-chronic-kidney-disease-100461044",false,"NCT05283512","Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease","Intravenous vs. Oral Hydration to Reduce the Risk of Post-Contrast Acute Kidney Injury After Intravenous Contrast-Enhanced Computed Tomography in Patients With Severe Chronic Kidney Disease (ENRICH): A Randomized Controlled Trial","ENRICH","Inclusion Criteria:\n\n* eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Scheduled for elective IV CECT\n* Age ≥ 18\n* Signed informed consent\n\nExclusion Criteria:\n\n* Allergy to Iodine\n* Pregnancy\n* Active dialysis treatment\n* Acute infectious or inflammatory disease\n* Acute pre- and\u002For post-renal kidney failure\n* Unable to understand study information","ALL","18 Years",{"count":94,"type":95},254,"ESTIMATED","INTERVENTIONAL",[98],"NA","The use of contrast media (CM) poses a risk of post-contrast acute kidney injury (PC-AKI), especially among patients chronic kidney disease (CKD). International guidelines recommend intravenous (IV) hydration with isotonic 0.9% NaCl for three-four hours pre-contrast and four-six hours post-contrast. Recent studies have proven that oral hydration or no hydration is non-inferior to IV hydration in patients with mild to moderate CKD (eGFR 30-60 mL\u002Fmin\u002F1.73 m2). However, no randomized controlled trials have evaluated alternative hydration methods against the guideline-recommended hydration protocol for the prevention of PC-AKI in high-risk patients with severe CKD (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2).\n\nThus, the main focus of this trial is to evaluate IV hydration vs. oral hydration for their efficacy to prevent of PC-AKI in patients with severe CKD, who are scheduled for an elective contrast-enhanced CT-scan (CECT) with IV contrast-administration.\n\nOur research hypotheses consist of the following:\n\n1. Oral hydration with bottled tap water is non-inferior to IV-hydration with isotonic 0.9% NaCl as renal prophylaxis to prevent PC-AKI in patients with severe CKD referred for an elective IV CECT.\n2. NGAL and cfDNA are early and precise plasma and urinary biomarkers of PC-AKI with excellent diagnostic and prognostic accuracy for PC-AKI, dialysis, renal adverse events, hospitalization, progression in CKD-symptoms, and all-cause mortality.",[101,102,103,104],"Contrast-induced Nephropathy","Kidney Injury","Kidney Failure, Chronic","Risk Reduction",[106,107,108,109,110,111,112],"Intravenous","Contrast material","Computed Tomography","Cardiac CT","Prophylaxis","Oral Hydration","IV-hydration","2025-07-29",{"date":115,"type":116},"2025-08-01","ACTUAL",{"date":118,"type":116},"2022-04-20",{"date":120,"type":95},"2027-12-31",{"name":5,"class":6},1]