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Alpha 2 adrenergic receptor agonists for the prevention of delirium and cognitive decline after open heart surgery (ALPHA2PREVENT): randomised controlled trial
EU CTIS ID: 2023-510212-39-00
What this study is testing
To prevent postoperative delirium
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Preoperative delirium (present at time of potential inclusion)
- Reduced peripheral autonomous activity (e.g. spinal cord injury)
- Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
- Endocarditis or sepsis
- Pheochromocytoma
- Planned deep hypothermia and circulatory arrest
See the full eligibility criteria
- 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.
- Preoperative delirium (present at time of potential inclusion)
- Reduced peripheral autonomous activity (e.g. spinal cord injury)
- Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin
- Endocarditis or sepsis
- Pheochromocytoma
- Planned deep hypothermia and circulatory arrest
- Emergency surgery, defined as less than 24 hours from admission to surgery
- Previously included in this study
- Not speaking or reading Norwegian
- Any other condition as evaluated by the treating physician
- Known hypersensitivity to the active ingredient or components of the product
- 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
- Uncontrolled hypotension
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.