Alpha 2 adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): randomised controlled trial

Ki vehet részt

• Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant must be ≥70 years old at the time of signing the informed consent. 2. Participant must be accepted for cardiac surgery with cardiopulmonary bypass. The surgical procedures may constitute 1) coronary bypass grafting, 2) tricuspid, mitral, or aortic valve replacement or repair, 3) surgery on the ascending aorta, and 4) the combination of any of these procedures. 3. Participant must be capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol

Ki nem vehet részt

• Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
• Emergency surgery, defined as less than 24 hours from admission to surgery
• Previously included in this study
• Bradycardia due to sick-sinus-syndrome, 2nd or 3rd degree AV-block (if not treated with pacemaker) or any other reason causing HR <50 bpm at time of inclusion
• Any other condition as evaluated by the treating physician
• Known hypersensitivity to the active ingredient or components of the product
• Ischemic stroke or transitory ischemic attack the last month or critical peripheral ischemia
• Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines
• Left ventricular ejection fraction < 40%
• Severe renal impairment (estimated GFR < 20 ml/min) or expected requirement for renal replacement therapy
• Severe hepatic dysfunction (liver enzyme three times the upper limit of normal together with a serum albumin concentration below the normal reference limit
• Preoperative delirium (present at time of potential inclusion)
• Reduced peripheral autonomous activity (e.g. spinal cord injury)
• Endocarditis or sepsis
• Pheochromocytoma
• Planned deep hypothermia and circulatory arrest
• Not speaking or reading Norwegian
• Uncontrolled hypotension