[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628267":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":25,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":25,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Gaziosmanpasa Research and Education Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Hydration Therapy","EXPERIMENTAL","Participants in the oral hydration group will receive 500 mL of drinking water 1 hour before the contrast-enhanced CT procedure. Following the procedure, they will receive 125 mL\u002Fhour of water for a total of 4 hours under nursing supervision. For patients with an ejection fraction (EF) \\\u003C40%, the hydration dose is halved: 250 mL before the procedure and 62.5 mL\u002Fhour for 4 hours post-procedure.",[13],"Dietary Supplement: Water",{"label":15,"type":16,"description":17,"interventionNames":18},"IV Hydration Therapy","ACTIVE_COMPARATOR","Participants in the intravenous (IV) hydration group will receive isotonic 0.9% NaCl solution. The protocol consists of 3 mL\u002Fkg for 1 hour before the procedure, followed by 2 mL\u002Fkg\u002Fhour for 4 hours post-procedure. For patients with an ejection fraction (EF) \\\u003C40%, the hydration dose is halved: 1.5 mL\u002Fkg before the procedure and 1 mL\u002Fkg\u002Fhour for 4 hours post-procedure.",[19],"Other: %0,9 NaCl",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Water",[9],null,{"type":27,"name":28,"description":17,"armGroupLabels":29,"otherNames":25},"OTHER","%0,9 NaCl",[15],[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":25,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Gaziosmanpasa Training and Research Hospital","RECRUITING","Istanbul","Gaziosmanpasa","34255","Turkey (Türkiye)",{"type":39,"coordinates":40},"Point",[41,42],28.94966,41.01384,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Alper G Cimen, MD","CONTACT","90+5353054720","alpercimen24@gmail.com",{"type":51,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100628267","oral-vs-intravenous-hydration-to-prevent-contrast-associated-acute-kidney-injury-in-the-ed-100628267",false,"NCT07459413","Oral vs. Intravenous Hydration to Prevent Contrast-Associated Acute Kidney Injury in the ED","Evaluation of the Effectiveness of Oral Hydration Compared to Intravenous Hydration in Preventing Contrast-Associated Acute Kidney Injury in the Emergency Department : A Randomized Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n* Patients aged 18 years and older.\n* Patients with an estimated Glomerular Filtration Rate (eGFR) between 15-59 mL\u002Fmin\u002F1.73 m².\n* Patients undergoing contrast-enhanced computed tomography (CT) in the emergency department.\n* Patients who have provided written informed consent.\n\nExclusion Criteria:\n\n* Pregnant women.\n* Patients with end-stage renal disease (ESRD) receiving dialysis or those with an eGFR \\\u003C15 mL\u002Fmin\u002F1.73 m².\n* Patients presenting with decompensated heart failure.\n* Patients with a known allergy to iodinated contrast media.\n* Patients with contrast media exposure within the last 72 hours.\n* Patients for whom oral intake is contraindicated or who cannot tolerate oral intake","ALL","18 Years",{"count":62,"type":63},198,"ESTIMATED","INTERVENTIONAL",[66],"NA","This study is planned to be conducted by emergency physicians between November 7, 2025, and December 7, 2026.\n\nInclusion and Exclusion Criteria The study will include adult patients aged 18 years and older who are considered at risk for Contrast-Associated Acute Kidney Injury (CA-AKI), with an estimated Glomerular Filtration Rate (eGFR) between 15-59 ml\u002Fmin\u002F1.73 m², a clinical indication for contrast-enhanced CT, and who have provided signed informed consent.\n\nExclusion criteria are as follows:\n\nPregnant women.\n\nPatients with a known contrast media allergy.\n\nContrast media exposure within the last 72 hours.\n\nEnd-stage renal disease (ESRD) with eGFR \\\u003C15 ml\u002Fmin\u002F1.73 m² or those receiving dialysis.\n\nPatients with clinical decompensated heart failure.\n\nPatients for whom oral intake is contraindicated or not tolerated.\n\nRandomization and Interventions Prior to randomization, the oral intake capacity of eligible patients will be verified. Participants will be randomized into two groups-IV hydration and oral hydration-at a 1:1 ratio using stratified block randomization based on age and gender.\n\nIV Hydration Group: Isotonic 0.9% NaCl solution will be administered. The regimen consists of 3 ml\u002Fkg for 1 hour pre-procedure, followed by 2 ml\u002Fkg\u002Fhour for 4 hours post-procedure. Patients with an ejection fraction (EF) \\\u003C40% will receive half-doses (1.5 ml\u002Fkg pre-procedure; 1 ml\u002Fkg\u002Fhour for 4 hours post-procedure).\n\nOral Hydration Group: Drinking water will be administered under nursing supervision. The regimen consists of 500 ml 1 hour pre-procedure and 125 ml\u002Fhour for 4 hours post-procedure. Patients with an EF \\\u003C40% will receive half-doses (250 ml pre-procedure; 62.5 ml\u002Fhour post-procedure).\n\nFollow-up and Outcome Measures Baseline renal function tests will be obtained from all patients prior to the protocol. Patients will be re-evaluated for CA-AKI via blood samples taken 48-72 hours after contrast administration.\n\nFurthermore, eGFR changes will be calculated using the Modification of Diet in Renal Disease (MDRD) formula. Mehran Risk Scores will also be determined for each patient. Long-term outcomes, including progression to ESRD (requirement for dialysis) and mortality within 1 month, as well as creatinine levels between days 30-45, will be assessed.",[69,70],"Contrast-Associated Acute Kidney Injury","Contrast-induced Nephropathy","2026-03-05",{"date":73,"type":74},"2026-03-09","ACTUAL",{"date":76,"type":74},"2025-11-07",{"date":78,"type":63},"2026-12-07",{"name":5,"class":6},1]