[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Romanian Society for Enteral and Parenteral Nutrition\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":122},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100601668","phase-3-remimazolam-vs-midazolam-for-sedation-and-cognitive-outcomes-in-orthopedic-surgery-100601668",false,"NCT07113483","Remimazolam vs. Midazolam for Sedation and Cognitive Outcomes in Orthopedic Surgery","Randomized, Double-Blind, 2x2 Factorial Trial of Remimazolam vs. Midazolam on Sedation and Early Cognitive Outcomes in Patients Undergoing Traumatic or Non-Traumatic Orthopedic Surgery With Regional Anesthesia","REMIND-ORTHO","Inclusion Criteria:\n\n* Adults aged 65 years or older.\n* Scheduled for traumatic or non-traumatic orthopedic surgery under regional anesthesia.\n* Able to provide informed consent or have a legally authorized representative provide consent.\n\nExclusion Criteria:\n\n* Patient refusal to participate.\n* Mini-Cog score less than 3 (indicative of significant cognitive impairment).\n* Severe hepatic or renal failure.\n* Known allergy to benzodiazepines or propofol.\n* History of benzodiazepine dependence.","ALL","65 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This study aims to compare two medications, Remimazolam and Midazolam, used for sedation during orthopedic surgeries performed under regional anesthesia. We want to find out which medication provides better sedation during the procedure and which one affects early recovery of brain function after surgery.\n\nOlder adults (65 years and above) undergoing surgery for bone injuries or conditions will participate. We will monitor their sedation levels, blood pressure, heart rate, side effects, and how quickly they recover after surgery. We also want to see if either medication causes fewer problems with thinking and memory shortly after surgery.\n\nThe study is designed so neither the patients nor the medical staff know which medication is being given, to ensure unbiased results. Participants will be randomly assigned to receive either Remimazolam or Midazolam.\n\nThe information gathered will help doctors choose the safest and most effective sedative for older patients undergoing orthopedic surgeries, potentially improving patient comfort and recovery.",[27,28,29,30],"Postoperative Cognitive Dysfunction","Orthopedic Procedures","Postoperative Pain Management","Hip Fracture",[32,33,34,35,36,37,38],"Remimazolam","Midazolam","Regional Anesthesia","Sedation","Cognitive dysfunction","Elderly patients","Trauma","RECRUITING","2025-09-26",{"date":42,"type":43},"2025-10-01","ACTUAL",{"date":42,"type":21},{"date":46,"type":21},"2026-02-15",{"name":48,"class":49},"Romanian Society for Enteral and Parenteral Nutrition","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":70,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":50},"100555304","achieving-nutritional-target-in-critically-ill-patients-with-impaired-gastrointestinal-dysfunction-100555304","NCT06510348","Achieving nuTritional Target in criticAlly Ill patieNts With iMpairEd gastroiNtesTinal Dysfunction","ATTAINMENT","Inclusion Criteria:\n\n* All adults (\\> 18 years old)\n* Mechanical ventilation for more than four days,\n* Controlled shock state (hemodynamic and tissue perfusion goals are reached) - Impaired intestinal absorbtion, defiend by both ultrasound measurement of gastric residual volume and paracetamol absorbtion test\n\nExclusion Criteria:\n\n* patients on non-invasive mechanichal ventilation\n* contraindication for EN for \\> 48 h after admission\n* patients with gastrointestinal surgical intervention within 3 months,\n* history of malabsorption, inflammatory bowel disease\n* short bowel syndrom\n* anorexia nervosa\n* gastrointestinal bleeding\n* cirrhosis\n* traumatic brain injury\n* subarahnoidal hemorrhage\n* neoplasia\n* post cardiac arrest patients\n* patients on chronic therapy with corticosteroids\n* pregnant women.","18 Years",{"count":60,"type":21},164,[62],"NA","Clear study hypothesis \u002F research question\n\nIt has already been proven that a prolonged negative energy balance during intensive care stay is an independent risk factor for mortality. Although it was thought that achivieng optimal delivery of calories will prevent nutritional deficits in critically ill patients, published randomized controlled trials failed to confirm this hypothesis.\n\nCombinging enteral and parenteral support may be an efficent strategy to reach nutritional target in critically ill patients. According to the current guidelines the use of suplemental parenteral nutrition (SPN) should be considered when energy targets are not achieved by enteral (EN) route, however, no clear data regarding timing, amount and composition is specified. Moreover, based on recente published data overfeeding should also be avoided, considering the negative impact on outcome.\n\nNutritional support for critically ill patients was focused more on preventing caloric and protein deficits and no great emphasis was placed on the efficiency of intestinal absorption. Gastrointestinal dysfunction is a prevalent reported complication that may contribute to falling short of meeting nutritional goals. This encompasses a wide spectrum of symptoms, such as impaired gastric emptying, ileus or impaired intestinal absorbtion, exposing patients to feeding intolerance, malnutrition and worse outcomes. No standard definition and monitoring techniques are so far available for the diagnostic of feeding intolerance. Although increased gastric residual volume (GRV) is the most used parameter for highlighting feeding intolerance, a controversy regarding the adequate threshold of GRV persists. Acetaminophen absorption test has been previously proposed as a diagnostic tool to asses impaired gastric emptying and intestinal absorbtion.\n\nBesides intestinal absorbtion, efficient utilization of macronutients should also be assessed, considering that critically ill patients have varying metabolic conditions and may not be able to metabolically handle adminsitered substrates. As a result body composition analysis should be taken into account in order to obtain a dynamic quantification, especially, of the mucle mass compartiments.\n\nTherefore the following low-interventional study is designed to investigate the hypothesis regarding energy and protein intake achievement in critically ill patients with diagnosed impaired gastrointestinal dysfunction to whom tailored nutritional support is administered.\n\nTaking into account that we aim to identify patients with early-phase gastrointestinal dysfunction impaired gastric emptying and reduced intestinal absorbtion (diagnosed using ultrasound gastric residual volume and byacetaminiphen absorbtion test) will serve as defining factors. Patients will be randomized to receive nutritional support either according to the EN protocol or enteral trophic feed + SPN protocol.\n\nDifferences in rectus femoris thickness measured on admission, on day 10 and 15, variation of lean body mass measured by bioelectrical impedance on admission on day 10 and 15, and differences between groups in muscle function using handgrip dynamometer will also be evaluated in both groups.",[65,66,67,68,69],"Parenteral Nutrition","Gastroparesis","Gastrointestinal Dysfunction","Protein Deficiency","Critical Illness",[71,72,73,74,75,76,77,78,79],"gastrointestinal dysfunction","supplemental parenteral nutrition","parenteral nutrition","enteral nutrition","critically ill","protein intake","calorie intake","gastroparesis","malabsorption","2024-11-04",{"date":82,"type":43},"2024-11-06",{"date":84,"type":43},"2024-10-01",{"date":86,"type":21},"2026-12-31",{"name":48,"class":49},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":96,"targetDuration":98,"studyType":99,"phases":4,"briefSummary":100,"conditions":101,"keywords":107,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":50},"100488978","impact-of-very-high-protein-content-enteral-nutrition-formulas-on-critically-ill-multiple-trauma-patients-100488978","NCT05647135","ImpACt of Very High Protein Content Enteral nUtrition Formulas on Critically Ill MUltipLe trAuma paTiEnts","ImpACt of Very High Protein Content Enteral nUtrition Formulas on Protein Metabolism and Residual Gastric Volume in Critically Ill MUltipLe trAuma paTiEnts","ACCUMULATE","Inclusion Criteria:\n\n* Adult patients (\\>18 yrs) admitted to the ICU\n* Multiple trauma (Injury severity score \\> 18)\n* Intubation and mechanical ventilation upon admission in ICU or during the first 24 hours of admission, for at least 48 h\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant women\n* Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation\n* Patients with enteral feeding contraindication 48 h after admission\n* Patients with recent gastrointestinal surgical intervention\n* Patients on chronic therapy with corticosteroids",{"count":97,"type":21},70,"8 Weeks","OBSERVATIONAL","This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content.\n\n* Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content\n* Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content\n* Differences regarding body composition when using enteral nutrition formulas with different protein content",[102,38,103,104,66,105,106],"Metabolism","Nutritional Deficiency","Protein Malnutrition","Muscle Loss","Calorie Malnutrition Protein",[74,108,109,110,111,112,113],"multiple trauma","energy target","protein target","body composition","gastric residual volume","enteral nutrition intolerance","2024-07-17",{"date":116,"type":43},"2024-07-22",{"date":118,"type":43},"2023-03-01",{"date":120,"type":21},"2024-12-01",{"name":48,"class":49},""]