Trial reportIntensive care medicine2025
Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial.
Trial report in Intensive care medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03317067 (Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
Who cites it
4 citing papers in PubMed.
- Neurotoxicity of ICU sedatives: we should end the surrogate debate and standardize long-term brain outcomes with a core neuro-outcome set.Intensive care medicine · 2026Article
- Article
- Dexmedetomidine Dosing Strategies in Sedation and Anesthesia: Pharmacokinetics, Safety, and Clinical Applications - A Narrative Review.Drug design, development and therapy · 2026Review
- When the sirens of statistics eclipse the clinical question.Intensive care medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
16 authors.
Funding
Abstract
purposeWhether dexmedetomidine improves the control of hyperactive delirium in non-intubated intensive care unit (ICU) patients as compared with placebo remains uncertain.
methodsIn a multicenter, double-blind, placebo-controlled, two-arm, investigator-initiated, randomized trial conducted in 9 ICUs, we randomly assigned non-intubated critically ill adults with hyperactive delirium to receive continuous intravenous infusion of dexmedetomidine or placebo for at least 36 h. The primary outcome was a joint modelling of multiple outcomes of agitation duration (score of + 1 or higher on the Richmond agitation-sedation scale), delirium duration, or the need for intubation and deep sedation. Key secondary outcomes included the occurrence of complications (such as bradycardia or hypotension), length of stay in ICU, or death.
resultsEnrollment occurred from December 2017 to February 2022. Final follow-up was in February 2023. The study was stopped for efficacy at the time of the preplanned interim analysis. Among the 151 patients who were included in the final analysis, the between-group difference in the primary outcome was statistically significant (median difference, -30 points; 95% CI, - 49 to - 12, p = 0.001). Agitation duration was shorter in the dexmedetomidine group (1.0 (1.0-2.0) vs 2.0 (1.0-7.0) hours, absolute difference 95% CI - 1.0 (- 2.0 to - 0.1); ES, - 0.60; 95% CI, -0.92 to -0.27, p = 0.001). Other key secondary outcomes were similar between groups.
conclusionIn non-intubated adult ICU patients with hyperactive delirium, the use of dexmedetomidine was associated with a greater clinical benefit than placebo for the joint modelling of multiple endpoints of agitation control, delirium resolution, and intubation with mechanical ventilation. Dexmedetomidine appears to be a valuable alternative that significantly reduced the median duration of agitation by approximately 1 h compared to placebo in hyperactive delirious non-intubated intensive care unit patients.
trial registrationClinicalTrial.gov Identifier: NCT03317067. Registration on October 17th, 2017 prior to first patient inclusion. https://clinicaltrials.gov/search?term=NCT03317067 .
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