drugset / Trial / NCT03477344
Dexmedetomidine After Cardiac Surgery for Prevention of Delirium
Phase 3
Completed
348 enrolled
University Hospital, Brest
Baxter Healthcare Corporation · collabDirection Générale de l'Offre de Soins · collab
RandomizedParallel-groupQuadruple-blindTreatment
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 population of post cardiac surgery patients. This population is characterized by longer ICU stay, more physical restraints such as catheters and drains, pain and sleep deprivation. It is associated with higher prevalence of Delirium and agitation leading to exposure to severe agitation related adverse events.
Timeline
- Start
- 2019-01-04
- Primary completion
- 2021-06-29
- Completion
- 2021-06-29
Publications
- Huet O, Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Bougle A, Kerforne T, Lasocki S, Eljezi V, Dessertaine G, Amour J, Chapalain X; EXACTUM and the Atlanrea Study Group. Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: a pragmatic, randomized, double-blind, placebo-controlled trial. Crit Care. 2024 Feb 29;28(1):64. doi: 10.1186/s13054-024-04842-1.
- Gargadennec T, Oilleau JF, Rozec B, Nesseler N, Lasocki S, Futier E, Amour J, Durand M, Bougle A, Kerforne T, Consigny M, Eddi D, Huet O. Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial. BMJ Open. 2022 Apr 8;12(4):e058968. doi: 10.1136/bmjopen-2021-058968.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Dexmedetomidine | Other / unclassified | 0.4 ug/ml | Intravenous |