Dexmedetomidine or Clonidine Infusion for Prevention of Delirium After Open Heart Surgery

Last updated: April 29, 2024
Sponsor: Oslo University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Memory Problems

Memory Loss

Alzheimer's Disease

Treatment

Dexmedetomidine

Clonidine

Natriumchlorid

Clinical Study ID

NCT05029050
2021-001645-12
2021-001645-12
  • Ages > 70
  • All Genders

Study Summary

A parallel-group treatment, five-centre, participant and investigator masked, three-arm study to assess the safety and effectiveness of dexmedetomidine or clonidine infusion compared to placebo for the prevention of delirium and cognitive decline in male and female participants aged 70+ scheduled for open heart surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteriaapply:

  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. Thesurgical procedures may constitute 1) coronary bypass grafting, 2) tricuspid, mitral,or aortic valve replacement or repair, 3) surgery on the ascending aorta, and 4) thecombination any of these procedures.
  3. Participant must be capable of giving signed informed consent.

Exclusion

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 treatedwith 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 peripheralischemia 9. Acute coronary syndrome last 24 hours. Acute coronary syndrome is defined according tointernational guidelines 10. Left ventricular ejection fraction < 40% 11. Severe renal impairment (estimated GFR <20ml/min) or expected requirement for renalreplacement therapy 12. Severe hepatic dysfunction (liver enzyme three times the upper limit of normaltogether 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

Study Design

Total Participants: 900
Treatment Group(s): 3
Primary Treatment: Dexmedetomidine
Phase: 4
Study Start date:
January 17, 2022
Estimated Completion Date:
January 31, 2025

Study Description

Delirium is a major public health concern without therapeutic options. It is an acute disturbance of attention and cognition, precipitated by an acute somatic condition. Delirious patients are often subject to off-label treatment with psychotropic drugs that have dubious effects.

The intravenous alpha-2-adrenergic receptor agonist dexmedetomidine, attenuating sympathetic nervous system activity, shows promise as treatment for delirium, but its use is limited to intensive care units (ICU). Its long-term cognitive effects are unknown. Clonidine is a pharmacodynamically similar drug that can be given orally and has been used for decades as an antihypertensive agent, but is else sparsely studied.

ALPHA2PREVENT will be a three-armed randomised controlled trial to study 1) whether repurposing of clonidine can represent a novel treatment option for delirium, and 2) the possible effects of both dexmedetomidine and clonidine on long-term cognitive trajectories, motor activity patterns, patient rated outcome measures and biomarkers of neuronal injury.

Connect with a study center

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Oslo University Hospital Rikshospitalet

    Oslo,
    Norway

    Active - Recruiting

  • Oslo University Hospital Ullevål

    Oslo,
    Norway

    Active - Recruiting

  • University Hospital of North Norway

    Tromsø,
    Norway

    Active - Recruiting

  • St Olav University Hospital

    Trondheim,
    Norway

    Active - Recruiting

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