[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620490":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":42,"locations":51,"responsibleParty":95,"collaborators":98,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":46,"enrollmentInfo":111,"targetDuration":46,"studyType":114,"phases":115,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":126,"whyStopped":46,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Centre of Postgraduate Medical Education","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Single-shot spinal anaesthesia","EXPERIMENTAL","Bolus dose of Bupivacaine Spinal 0,5% Heavy",[13],"Drug: Bupivacaine Spinal 0,5% Heavy - bolus",{"label":15,"type":10,"description":16,"interventionNames":17},"Continuous spinal anaesthesia","Dose titration of Bupivacaine Spinal 0,5% Heavy",[18],"Drug: Bupivacaine Spinal 0,5% Heavy - titration",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Bupivacaine Spinal 0,5% Heavy - bolus","Group 1 (Control Group) will receive single-shot spinal anesthesia with a bolus of 0.5% hyperbaric bupivacaine, with the dose adjusted according to the patient's weight and height to achieve a sensory block up to the T12 dermatome. The operating table will be kept in a neutral position.",[9],[26],"Single bolus",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Bupivacaine Spinal 0,5% Heavy - titration","Group 2 (Interventional Group) will receive continuous spinal anesthesia administered via a dedicated intrathecal catheter. An initial induction dose of 1 ml of 0.5% hyperbaric bupivacaine will be administered, followed by titrated boluses of 0.5 ml every 15 minutes until a sensory block to the T12 dermatome is achieved. Once the desired block height is established, the anesthetic level will be maintained by administering titrated doses of 0.5-1 ml approximately every hour. The operating table will be kept in a neutral position.",[15],[32],"Rose titration",[34,38],{"name":35,"affiliation":36,"role":37},"Rafał Kamiński, MD, PhD","Dept of Musculoskeletal Trauma Surg and Orthop, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP","STUDY_CHAIR",{"name":39,"affiliation":40,"role":41},"Magdalena Fleming, MD","Dept of Anesthesiology, Gruca Orthopaedic and Trauma Teaching Hospital, CMKP","PRINCIPAL_INVESTIGATOR",[43,48],{"name":39,"role":44,"phone":45,"phoneExt":46,"email":47},"CONTACT","00 48 509 995 408",null,"m.fleming@spskgruca.pl",{"name":35,"role":44,"phone":49,"phoneExt":46,"email":50},"0048 502 775 345","rkaminski@spskgruca.pl",[52,75],{"facility":53,"status":46,"city":54,"state":46,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Centre of Postgraduate Medical Education, Professor A. Gruca Teaching Hospital, Konarskiego 13 street","Otwock","05-400","Poland","PL",{"type":59,"coordinates":60},"Point",[61,62],21.26129,52.10577,{"lat":62,"lon":61},[65,68,72,73],{"name":35,"role":44,"phone":66,"phoneExt":46,"email":67},"00 48 22 788 56 75","kl.chir.ur@spskgruca.pl",{"name":69,"role":44,"phone":70,"phoneExt":46,"email":71},"Piotr Nowakowski, MD, PhD","00 48 22 779 40 31","x@spskgruca.pl",{"name":39,"role":41,"phone":46,"phoneExt":46,"email":46},{"name":69,"role":74,"phone":46,"phoneExt":46,"email":46},"SUB_INVESTIGATOR",{"facility":76,"status":46,"city":77,"state":46,"zip":78,"country":56,"countryCode":57,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"National Medical Institute of the Ministry of the Interior and Administration, Wołoska 137 street","Warsaw","02507",{"type":59,"coordinates":80},[81,82],21.01178,52.22977,{"lat":82,"lon":81},[85,89,93],{"name":86,"role":44,"phone":87,"phoneExt":46,"email":88},"Konstanty Szułdrzyński, MD, PhD","00 48 47 722 10 20","dyrekcja@cskmswia.gov.pl",{"name":90,"role":44,"phone":91,"phoneExt":46,"email":92},"Miłosz Jankowski, MD, PhD","00 48 47 722 14 50","anestezjologia@pimmswia.gov.pl",{"name":94,"role":41,"phone":46,"phoneExt":46,"email":46},"Rafał Mierzejewski, MD",{"type":41,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Rafał Kamiński","MD, PhD, Associate Professor, Chief of the Department of Orthopaedic and Trauma Surgery (Div. Knee Surg & Arthroscopy, Div. General Orthop Trauma, Div. Upper Limb Surg.) at Gruca Orthopaedic And Trauma Teaching Hospital",[99],{"name":100,"class":6},"Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland","100620490","phase-4-haemodynamic-effects-and-complications-of-continuous-versus-single-shot-spinal-anaesthesia-for-hip-fracture-surgery-100620490",false,"NCT07358299","Haemodynamic Effects and Complications of Continuous Versus Single-shot Spinal Anaesthesia for HIP Fracture Surgery","A Comparison of Haemodynamic Effects, as Assessed by Cardiac Output Monitoring, and Complications of Continuous Versus Single-Shot Spinal Anaesthesia for Hip-Fracture Surgery in Patients Over 50 Years of Age","CHIPS","Inclusion Criteria:\n\n* Age \\> 50 years, regardless of gender\n* Diagnosis of a proximal femur fracture\n* Orthopedic qualification for open reduction and internal fixation of the fracture\n* Informed consent for the surgical procedure\n* Informed consent for regional anesthesia, i.e., a central neuraxial block (spinal anesthesia)\n* Informed consent to participate in the study\n\nExclusion Criteria:\n\n* Age \\\u003C 50 years, regardless of gender\n* Refusal to consent to surgical treatment\n* Refusal to consent to regional anesthesia\n* Refusal to consent to participate in the study\n* Inability to provide informed consent\n* Allergy to local anesthetic agents\n* Severe congenital or acquired coagulation disorders\n* Failure to meet the recommended time interval between the last dose of an anticoagulant and central neuraxial blockade, according to the 2022 European Journal of Anaesthesiology (EJA) guidelines\n* Infection at the block site or a systemic infection (i.e., sepsis, septic shock)\n* Patients with multiple organ dysfunction syndrome requiring hospitalization in the Intensive Care Unit for stabilization of vital functions\n* Clinical signs of increased intracranial pressure or suspicion of an intracranial mass on imaging studies\n* Other contraindications to spinal anesthesia as judged by the qualifying physician","ALL","50 Years",{"count":112,"type":113},216,"ESTIMATED","INTERVENTIONAL",[116],"PHASE4","This research project aims to identify a safer method of spinal anaesthesia for elderly patients undergoing surgical stabilisation of proximal femoral fractures.\n\nThe study's primary objective is to compare two spinal anaesthesia techniques: the continuous method (investigational), which allows titration of local anaesthetic doses through a catheter placed in the subarachnoid space, and the conventional single-shot bolus injection.\n\nThe main hypothesis is that the continuous catheter technique reduces the incidence of intraoperative hypotension and related complications, such as delirium, acute kidney injury, and cardiovascular events.\n\nBeyond haemodynamic stability-assessed through advanced continuous monitoring of cardiac output and vascular resistance-the study will evaluate early and late complications, as well as quality of life up to 24 months post-surgery.\n\nThe project is a prospective, randomised, multicentre clinical trial including at least 216 patients over 50 years of age, randomly assigned to one of the two groups.\n\nProximal femoral fractures are a major and growing global health issue, particularly among geriatric patients with multiple comorbidities. The conventional single-shot spinal anaesthesia, though widely used, carries a high risk of hypotension, potentially leading to delirium, acute kidney injury, stroke, and cardiac events. These complications worsen prognosis, decrease quality of life, and increase mortality.\n\nMost existing studies are over two decades old, based on small cohorts and outdated anaesthetic protocols, and lack long-term follow-up data (\\>30 days) on neurological outcomes, functional recovery, quality of life, and mortality. Moreover, no modern trials have provided direct, comprehensive comparisons between single-shot and continuous spinal anaesthesia.\n\nThis project therefore seeks to fill this critical evidence gap through a robust randomised clinical trial. Using precise, continuous measurements of arterial pressure, vascular resistance, and cardiac output, alongside long-term assessments of neurological outcomes, quality of life, and survival, it aims to determine whether continuous spinal anaesthesia offers superior safety and should become the new standard of care for this vulnerable population.",[119,120],"Anesthesia, Spinal","Hip Fractures",[15,122,123,124,125],"Late side effects of spinal anaesthesia","Haemodynamic stability","Follow-up care after proximal femoral fractures","Quality of life after proximal femoral fractures","NOT_YET_RECRUITING","2026-01-21",{"date":129,"type":130},"2026-01-23","ACTUAL",{"date":132,"type":113},"2026-01-15",{"date":134,"type":113},"2029-11-01",{"name":5,"class":6},2]