Status:
COMPLETED
Dexmedetomidine After Cardiac Surgery for Prevention of Delirium
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Direction Générale de l'Offre de Soins
Baxter Healthcare Corporation
Conditions:
ICU Delirium
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
We designed a prospective, double blind, randomized, controlled versus placebo study to evaluate the efficacy of nightly low dose of Dexmedetomidine infusion to promote sleep and lower delirium in a p...
Detailed Description
Delirium occurs in about 25% of patients after cardiac surgery. It is an independent factor of poor outcome and recovery after ICU stay as it is associated with mortality and impaired mental function ...
Eligibility Criteria
Inclusion
- patients aged 65 or more who undergo cardiac surgery on and off-pump: coronary artery bypass graft, cardiac valve replacement or both.
- Consent signed
Exclusion
- history of mental illness, dementia
- inclusion in another study evaluating sedation or pain
- length of stay in ICU less than 24 hours
- alpha 2 agonists allergy
- surgery performed in an immediate emergency situation
- uncontrolled hypotension
- second and third degree atrioventricular block without pacemaker
- severe hepatic insufficiency
- acute cerebrovascular diseases
- patient treated with clonidine
- patient with disturbed preoperative liver assessment (hepatocellular insufficiency)
- patient under guardianship or curatorship
Key Trial Info
Start Date :
January 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
348 Patients enrolled
Trial Details
Trial ID
NCT03477344
Start Date
January 4 2019
End Date
June 29 2021
Last Update
June 22 2022
Active Locations (9)
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1
Angers university hospital
Angers, France
2
CHRU de Brest
Brest, France, 29609
3
Clermont Ferrand university hospital
Clermont-Ferrand, France
4
CHU de Grenoble
Grenoble, France, 38000