Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

Summary

The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients

Timeline

Start

2017-12-21

Primary completion

2021-05-21

Completion

2023-02-23

Outcome

Met primary endpoint

paper the between-group difference in the primary outcome was statistically significant (median difference, -30 points; 95% CI, - 49 to - 12, p = 0.001). PMID 41160116 ↗

paper dexmedetomidine was associated with a greater clinical benefit than placebo for the joint modelling of multiple endpoints PMID 41160116 ↗

Publications

• Results Godet T, Louis C, Rieu B, De Jong A, Couhault P, Pradel G, Tete H, Bourguignon N, Borao L, Jabaudon M, Futier E, Jaber S, Pereira B, Chanques G, Constantin JM; 4D study group. Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial. Intensive Care Med. 2025 Dec;51(12):2305-2317. doi: 10.1007/s00134-025-08135-1. Epub 2025 Oct 29.
• Louis C, Godet T, Chanques G, Bourguignon N, Morand D, Pereira B, Constantin JM; AZUREA network. Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial. Trials. 2018 Jun 4;19(1):307. doi: 10.1186/s13063-018-2656-x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexmedetomidine	Other / unclassified	—	Intravenous

Indications