Using dexmedetomidine or clonidine to prevent delirium after heart surgery
Alpha 2 Adrenergic Receptor Agonists for the Prevention of Delirium and Cognitive Decline After Open Heart Surgery (ALPHA2PREVENT): Randomised Controlled Trial.
This study is testing whether giving older patients dexmedetomidine or clonidine during heart surgery can help prevent confusion and memory problems afterward.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 900 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 5 sites (Bergen and 4 other locations) |
| Trial ID | NCT05029050 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of dexmedetomidine and clonidine infusions compared to a placebo in preventing delirium and cognitive decline in patients aged 70 and older undergoing open heart surgery. It is a three-arm, randomized controlled trial conducted across five centers, where participants and investigators are masked to treatment assignments. The study aims to explore the potential of repurposing clonidine as a treatment option for delirium and to assess the long-term cognitive effects of both medications.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older who are scheduled for open heart surgery requiring cardiopulmonary bypass.
Not a fit: Patients with preoperative delirium or significant cardiac issues such as bradycardia or uncontrolled hypotension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new preventive treatment for delirium, improving cognitive outcomes for elderly patients after heart surgery.
How similar studies have performed: While the use of dexmedetomidine in ICU settings has shown promise, the repurposing of clonidine for this purpose is less studied, making this approach somewhat novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 any of these procedures. 3. Participant must be capable of giving signed informed consent. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 4. Preoperative delirium 5. Known hypersensitivity to the active ingredient or components of the product 6. 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 7. Uncontrolled hypotension 8. Ischemic stroke or transitory ischemic attack the last month or critical peripheral ischemia 9. Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according to international guidelines 10. Left ventricular ejection fraction \< 40% 11. Severe renal impairment (estimated GFR \<20ml/min) or expected requirement for renal replacement therapy 12. Severe hepatic dysfunction (liver enzyme three times the upper limit of normal together with a serum albumin concentration below the normal reference limit) 13. Reduced peripheral autonomous activity (e.g. spinal cord injury) 14. Current use of tricyclic antidepressants, monoamine reuptake inhibitors or ciclosporin 15. Endocarditis or sepsis 16. Pheochromocytoma 17. Planned deep hypothermia and circulatory arrest 18. Emergency surgery, defined as less than 24 hours from admission to surgery 19. Previously included in this study 20. Not speaking or reading Norwegian 21. Any other condition as evaluated by the treating physician
Where this trial is running
Bergen and 4 other locations
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Oslo University Hospital Rikshospitalet — Oslo, Norway (Recruiting)
- Oslo University Hospital Ullevål — Oslo, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St Olav University Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Bjørn Erik Neerland, PhD — Oslo University Hospital
- Study coordinator: Bjørn Erik Neerland, PhD
- Email: bjonee@ous-hf.no
- Phone: +4790078979
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.