[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-brain-injuries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-brain-injuries":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629975","phase-4-effects-of-recombinant-human-growth-hormone-in-elderly-patients-with-moderate-to-severe-acute-brain-injury-gh-abi-rct-100629975",false,"NCT07481656","Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)","A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia","GH-ABI-RCT","Inclusion Criteria:\n\n1. Age ≥ 60 years, male or female.\n2. Hospitalized patients with acute brain injury (including traumatic brain injury, ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) who had a Glasgow Coma Scale (GCS) score ≤ 12 at any time during hospitalization.\n3. Presence of hypoalbuminemia, defined as serum albumin \\\u003C 35 g\u002FL and\u002For prealbumin \\\u003C 200 mg\u002FL after admission.\n4. Willing and able to provide informed consent (by patient or legal representative).\n\nExclusion Criteria:\n\n1. Unstable vital signs, defined as deviations in body temperature, respiration, pulse, blood pressure, or oxygen saturation from normal ranges that, in the clinical judgment of the investigator, may jeopardize vital organ perfusion or indicate disease progression.\n2. Active malignancy or history of malignancy with a disease-free interval of less than 5 years.\n3. Diabetes mellitus with retinopathy.\n4. Any other condition deemed unsuitable for participation by the investigator (e.g., severe renal\u002Fhepatic dysfunction, active infection, known hypersensitivity to growth hormone, or participation in another interventional trial).","ALL","60 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia.\n\nEligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.\n\nEligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.\n\nClinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes.\n\nSafety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.",[27,28],"Acute Brain Injuries","Moderate to Severe Traumatic Brain Injury",[30,31,32,28],"recombinant human growth hormone","rhGH","hypoproteinemia","NOT_YET_RECRUITING","2026-03-16",{"date":36,"type":37},"2026-03-19","ACTUAL",{"date":39,"type":21},"2026-04-10",{"date":41,"type":21},"2028-10-30",{"name":43,"class":44},"Anhui Provincial Hospital","OTHER_GOV",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":56,"studyType":57,"phases":4,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":5},"100627574","pkpd-target-attainment-of-ceftriaxone-for-the-prevention-of-early-ventilator-associated-pneumonia-in-neurologically-injured-patients-100627574","NCT07450404","PK\u002FPD Target Attainment of Ceftriaxone for the Prevention of Early Ventilator-associated Pneumonia in Neurologically Injured Patients","NeuroPKVAP","Inclusion Criteria:\n\n* 18 years or older\n* Admitted in intensive care unit for acute brain injury, including traumatic brain injury and cerebral vascular disease\n* Glasgow coma scale inferior to 12\n* Orotracheal intubation in first 12 hours of admission\n* Needed of invasive mechanical ventilation for at least 48 hours\n\nExclusion Criteria:\n\n* Acute brain injury related to tumoral or infectious process\n* Antibiotic therapy administered before acute brain injury for an other pathology\n* Patients with a risk of multiresistance bacteria contamination (stay in a risk area in the past 3 months, antibiotic therapy with fluoroquinolone or betalctamine in the past 3 months, hospitalization in last month before admission, documented contaminationwith multiresistance bacteria, immunodepression)\n* Patients with hish risk of death in the first 48 hours\n* Patients with a beta-lactams reported allergy","18 Years",{"count":55,"type":21},60,"28 Days","OBSERVATIONAL","Critically ill patients admitted for acute brain injury are exposed to many heath-care associated infections such as ventilator associated pneumoniae (VAP). The PROHYVAP study, published in 2024 reported that a single dose of CEFTRIAXONE as an antibiotic prophylaxis could reduce the incidence of early VAP (VAP that occured between day 2 and day 7 of mechanical ventilation).\n\nHowever, patients with acute brain injury also presented frequently augmented renal clearance (ARC), which could affect the pharmacokinetic and pharmacodynamic target attainment (PK\u002FPD) of antibiotic prophylaxis.\n\nThis study aims to analyse the PK\u002FPD target attainment after one dose of CEFTRIAXONE in critically ill patients with acute brain injury and to describe the effect of ARC on PK\u002FPD target attainment during early VAP.",[60,27],"Early Ventilator Associated Pneumonia",[62,63,64,65],"Antibiotic prophylaxis","ventilator associated pneumonia","augmented renal clearance","PK\u002FPD target attainment","2026-03-02",{"date":68,"type":37},"2026-03-04",{"date":70,"type":21},"2026-03-01",{"date":72,"type":21},"2027-10-01",{"name":74,"class":75},"Central Hospital, Nancy, France","OTHER"]