[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535403":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":68,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":95,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"St. Joseph's Healthcare Hamilton","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dexmedetomidine Intervention","EXPERIMENTAL","Patients randomized to the experimental arm will receive dexmedetomidine. The study medication will be reconstituted by mixing 4 vials (8 ml) into a 100 ml bag of normal saline or 5% dextrose, this is the preferred dilution, or 2 vials (4ml) into 50 ml syringe to an equivalent concentration of 8 mcg\u002Fml of dexmedetomidine. The constituted infusion is stable at room temperature for up to 24 hours.\n\nThe recommended starting infusion rate is equivalent to 1 µg\u002Fkg\u002Fh of dexmedetomidine, without loading or bolus. This will be titrated to an equivalent dexmedetomidine dose of 0 to 1.0 µg\u002Fkg\u002Fh according to study algorithm to maintain target sedation of Richmond Agitation-Sedation Scale (RASS) score of -1 to +1.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Intervention","PLACEBO_COMPARATOR","Those in the control group will receive a placebo that is identical in colour and packaging and at equal volume to the intervention group. The placebo is a matching vial containing 2 mL sterile normal saline.",[19],"Other: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Dexmedetomidine is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Normal saline placebo will be given as continuous infusion.",[15],[32],{"name":33,"affiliation":34,"role":35},"Kimberley Lewis, MD","St. Joseph's Healthcare Hamilton\u002FMcMaster University","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Jose Estrada","CONTACT","905-522-1155","32873","jestrada@stjosham.on.ca",{"name":44,"role":39,"phone":26,"phoneExt":26,"email":45},"Irene Armanious","iarmanio@stjosham.on.ca",[47],{"facility":48,"status":26,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Mount Sinai Hospital","Toronto","Ontario","M5G 1X5","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.39864,43.70643,{"lat":58,"lon":57},[61,66],{"name":62,"role":39,"phone":63,"phoneExt":64,"email":65},"Sumesh Shah, CCRP","416-586-4800","1164","sumesh.shah@sinaihealth.ca",{"name":67,"role":35,"phone":26,"phoneExt":26,"email":26},"Samgeeta Mehta, MD",{"type":35,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Kimberley Lewis","Principal Investigator","100535403","phase-4-early-sedation-with-dexmedetomidine-vs-placebo-in-older-ventilated-critically-ill-patients-100535403",false,"NCT06251375","Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients","Sedation Practice in Intensive Care Evaluation (SPICE IV) Early Sedation With Dexmedetomidine vs. Placebo in Older Ventilated Critically Ill Patients: A Prospective, Multi-Centre, Double-Blind, Randomized, Controlled Trial","SPICEIV","Inclusion Criteria:\n\n1. Age ≥ 65 years\n2. Intubated and receiving invasive mechanical ventilation in an intensive care unit\n3. The treating clinicians believe that the patient will remain intubated and ventilated until the day after tomorrow (i.e. unlikely to be extubated the following day)\n4. The patient requires immediate ongoing sedative medication for comfort, safety and to facilitate the delivery of life support measures.\n\nExclusion Criteria:\n\n1. Has been intubated (excluding time spent intubated within an operating theatre or transport) for greater than 12 hours, with an additional 6-hour grace period, a total of 18 hours, in an intensive care unit\n2. Proven or suspected acute primary brain lesion such as traumatic brain injury, haemorrhage, stroke, or hypoxic brain injury\n3. Proven or suspected spinal cord injury or other pathology that may result in permanent or prolonged weakness\n4. Admission as a consequence of a suspected or proven drug overdose or burns\n5. Administration of or need for ongoing neuromuscular blockade\n6. A mean arterial blood (MAP) pressure that is less than 50 mmHg, despite adequate resuscitation and vasopressor support at time of randomization\n7. Heart rate less than 55 beats per minute or a high grade atrio-ventricular block in the absence of a functioning pacemaker\n8. Known sensitivity to dexmedetomidine\n9. Acute fulminant hepatic failure with EITHER\n\n   1. hepatic encephalopathy OR\n   2. bilirubin (\\>300 µmol\u002Fl) and INR (\\>3.5), or both, without prior hepatic dysfunction.\n10. Receiving full time residential nursing care\n11. Death is deemed both imminent and inevitable and either the attending physician, patient or substitute decision maker is not committed to active treatment\n12. Underlying disease that makes survival to 90 days unlikely\n13. Previously enrolled in the SPICE IV study","ALL","65 Years",{"count":82,"type":83},300,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","Sedation remains a ubiquitous and crucial component of intensive care treatments in critically ill mechanically ventilated patients. Sedation relieves anxiety, reduces distress, and promotes tolerance of endotracheal intubation and associated life-sustaining interventions such as mechanical ventilation, cardiovascular assistance, and renal support. Thus, choosing the optimal sedative agent is vital to patient comfort, safety, and survival. Despite more than 20 years of intensive care sedation research, there is still no consensus on what constitutes best sedation practice. The Society of Critical Care Medicine, the premier critical care organisation in North America, published the 2018 Clinical Practice Guidelines on the management of Pain, Agitation\u002FSedation, Delirium, Immobility and Sleep (PADIS) disruption (chaired by our primary applicant W.A.) and issued weak recommendations to provide analgesia before sedation, to target light sedation whenever clinically feasible, and to use either dexmedetomidine or propofol over midazolam for the sedation of mechanically ventilated critically ill patients. Similarly, the American Thoracic Society produced a set of Clinical Practice Guidelines to promote liberation and weaning from mechanical ventilation in critically ill patients, with weak recommendations for the use of non-benzodiazepines as primary sedatives and to target light sedation when clinically possible. A weak recommendation was issued in an Intensive Care Medicine Rapid Practice Guideline published in 2022 to use dexmedetomidine over propofol for sedation of critically ill adults, if the desired outcome is a reduction in delirium. These guidelines, however, do not consider age-dependent pharmacokinetics and pharmacodynamics, illness severity, timing of sedative administration, operative vs medical reason for admission, or the changing dynamics of sedation practice at different phases of critical illness. The lack of high-level evidence to inform sedation practice in the critically ill has led to approaches that are mainly opinion-based and lack the support of evidence from large multicentre, international randomised clinical trials.",[89],"Respiratory Insufficiency",[91,92,93,94],"Mechanical Ventilation","Sedation","Randomized Control Trial","Acute Respiratory Failure","NOT_YET_RECRUITING","2025-09-03",{"date":98,"type":99},"2025-09-10","ACTUAL",{"date":101,"type":83},"2025-09-07",{"date":103,"type":83},"2028-01-31",{"name":5,"class":6},1]