Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Apr 8;12(4):e058968.
doi: 10.1136/bmjopen-2021-058968.

Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial

Thomas Gargadennec  1   2 , Jean-Ferréol Oilleau  3   2 , Bertrand Rozec  4   5 , Nicolas Nesseler  6 , Sigismond Lasocki  7   8 , Emmanuel Futier  9   10 , Julien Amour  11 , Michel Durand  12 , Adrien Bougle  13   14 , Thomas Kerforne  15   16 , Maëlys Consigny  17 , Dauphou Eddi  17 , Olivier Huet  3   2
Affiliations

Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial

Thomas Gargadennec et al. BMJ Open. .

Abstract

Introduction: Incidence of delirium after cardiac surgery remains high and delirium has a significant burden on short-term and long-term outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Preserving the circadian rhythm with overnight infusion of low-dose dexmedetomidine has been shown to lower the occurrence of delirium in older patients after non-cardiac surgery. However, these results remain controversial. The aim of this study was to demonstrate the usefulness of sleep induction by overnight infusion of dexmedetomidine to prevent delirium after cardiac surgery.

Methods and analysis: Dexmedetomidine after Cardiac Surgery for Prevention of Delirium is an investigator-initiated, randomised, placebo-controlled, parallel, multicentre, double-blinded trial. Nine centres in France will participate in the study. Patients aged 65 years or older and undergoing cardiac surgery will be enrolled in the study. The intervention starts on day 0 (the day of surgery) until intensive care unit (ICU) discharge; the treatment is administered from 20:00 to 08:00 on the next day. Infusion rate is modified by the treating nurse or the clinician with an objective of Richmond Agitation and Sedation Scale score from -1 to +1. The primary outcome is delirium occurrence evaluated with confusion assessment method for the ICU two times per day during 7 days following surgery. Secondary outcomes include incidence of agitation related events, self-evaluated quality of sleep, cognitive evaluation 3 months after surgery and quality of life 3 months after surgery. The sample size is 348.

Ethics and dissemination: The study was approved for all participating centers by the French Central Ethics Committee (Comité de Protection des Personnes Ile de France VI, registration number 2018-000850-22). The results will be submitted for publication in peer-reviewed journals.

Trial registration number: NCT03477344.

Keywords: Cardiac surgery; Delirium; Dexmedetomidine; Intensive care.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study calendar. CAM-ICU, confusion assessment method for the intensive care unit.
Figure 2
Figure 2
Consolidated Standards of Reporting Trials diagram of the study. ICU, intensive care unit.
Figure 3
Figure 3
Management of the study treatment from production to infusion. ICU, intensive care unit.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Brown CH, Probert J, Healy R, et al. . Cognitive decline after delirium in patients undergoing cardiac surgery. Anesthesiology 2018;129:406–16. 10.1097/ALN.0000000000002253 - DOI - PMC - PubMed
    1. McPherson JA, Wagner CE, Boehm LM, et al. . Delirium in the cardiovascular ICU: exploring modifiable risk factors. Crit Care Med 2013;41:405–13. 10.1097/CCM.0b013e31826ab49b - DOI - PMC - PubMed
    1. Ely EW, Margolin R, Francis J, et al. . Evaluation of delirium in critically ill patients: validation of the confusion assessment method for the intensive care unit (CAM-ICU). Crit Care Med 2001;29:1370–9. 10.1097/00003246-200107000-00012 - DOI - PubMed
    1. Ely EW, Shintani A, Truman B, et al. . Delirium as a predictor of mortality in mechanically ventilated patients in the intensive care unit. JAMA 2004;291:1753. 10.1001/jama.291.14.1753 - DOI - PubMed
    1. Salluh JIF, Wang H, Schneider EB, et al. . Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ 2015;350:h2538.10.1136/bmj.h2538 - DOI - PMC - PubMed

Publication types

Substances

Associated data