NCT03477344 (EXACTUM) is a Phase 3 clinical trial of Dexmedetomidine in ICU Delirium, sponsored by University Hospital, Brest.

Who is sponsoring NCT03477344?

NCT03477344 is sponsored by University Hospital, Brest.

What drugs are being tested in NCT03477344?

Interventions in NCT03477344: Dexmedetomidine, Sodium chloride 0.9%.

What condition does NCT03477344 study?

NCT03477344 studies ICU Delirium.

Is NCT03477344 still recruiting?

NCT03477344 is currently completed. Last updated 22 June 2022.

Last reviewed 2022-06-22 · How we verify

NCT03477344: EXACTUM

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Dexmedetomidine After Cardiac Surgery for Prevention of Delirium

Completed Phase 3 Last updated 22 June 2022

What this trial tests

Phase 3 trial testing Dexmedetomidine in ICU Delirium in 348 participants. Completed in 29 June 2021.

Timeline

4 January 2019

Primary endpoint
29 June 2021

29 June 2021

Quick facts

Lead sponsor	University Hospital, Brest
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	348
Start date	4 January 2019
Primary completion	29 June 2021
Estimated completion	29 June 2021
Sites	9 locations across France

Drugs / interventions tested

Dexmedetomidine (dexmedetomidine) — full drug profile →
Sodium chloride 0.9%

Conditions studied

ICU Delirium — all drugs for ICU Delirium →

Sponsor

University Hospital, Brest

Who can join

65 and older, any sex, with ICU Delirium. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: a pragmatic, randomized, double-blind, placebo-controlled trial.
Huet O, Gargadennec T, Oilleau JF, Rozec B, et al · · 2024 · cited 25× · PMID 38419119 · DOI 10.1186/s13054-024-04842-1
Dexmedetomidine after Cardiac Surgery for Prevention of Delirium (EXACTUM) trial protocol: a multicentre randomised, double-blind, placebo-controlled trial.
Gargadennec T, Oilleau JF, Rozec B, Nesseler N, et al · · 2022 · cited 7× · PMID 35396310 · DOI 10.1136/bmjopen-2021-058968
Prevention of post-operative delirium using an overnight infusion of dexmedetomidine in patients undergoing cardiac surgery: A pragmatic, randomised, double blind, placebo- controlled trial
Huet O, Gargadennec T, Oilleau J, Rozec B, et al · · 2023 · DOI 10.21203/rs.3.rs-3699822/v1

Verify or expand the search:

Other trials of Dexmedetomidine

Trials testing the same drug.

NCT06824077 — Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle · EARLY_PHASE1 · not yet recruiting
NCT07398066 — DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial) · NA · not yet recruiting
NCT07377981 — An Exploratory Study of the Efficacy and Safety of Esketamine and Dexmedetomidine in Non-Intubated ICU Patients With Hyp · Phase 4 · not yet recruiting
NCT07306702 — Dexmedetomidine-Enhanced PCIA After Lobectomy in Nicotine-Dependent Patients · Phase 4 · withdrawn
NCT07482540 — Role of Dexmedatomidine Drug in Prevention of Atrial Fibrillations Post Mitral Valve Surgery · NA · not yet recruiting

Other recruiting trials for ICU Delirium

Currently open trials in the same condition.

NCT06054828 — Modified Hospital Elder Life Program at Intensive Care Unit · NA · recruiting
NCT04876742 — Wheat Beer for Prevention of Delirium in Intensive Care Patients · NA · recruiting

Other University Hospital, Brest trials

Trials by the same sponsor.

NCT07526688 — Aerobic Physical Activity and Orofacial Myofascial Pain · NA · not yet recruiting
NCT07487155 — Unified Junction of Care, Integrated Treatments and Team Coordination for ADHD in Prison Settings With Substance Use Dis · NA · not yet recruiting
NCT07417605 — Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiatio · not yet recruiting
NCT07302074 — Understanding of Rare Inflammatory Arthritis in Comparison to Classical Inflammatory Arthritis : Tissular Observations a · NA · recruiting
NCT06441773 — Impact of Respiratory Rehabilitation on Quality of Life in Patients With Metastatic Non-small Cell Lung Cancer Treated W · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03477344 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Brest
Last refreshed: 22 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03477344.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing