Overview

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

Status:
Not yet recruiting

Trial end date:
2024-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oslo University Hospital

Collaborators:

Haukeland University Hospital
Sahlgrenska University Hospital, Sweden
St. Olavs Hospital
UMC Utrecht
University Hospital of North Norway

Treatments:

Clonidine
Dexmedetomidine

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) the combination of 1 and 2, and 4) surgery
on the ascending aorta

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