ICU sedation, delirium & recovery
Dexmedetomidine for treatment of hyperactive delirium in non-intubated intensive care unit (ICU) patients: the 4D randomized clinical trial
- stopped for efficacy at preplanned interim analysis
- Stopped for efficacy at the preplanned interim analysis
Authors' conclusion
In 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.
Study context
- Population
- Non-intubated critically ill adults with hyperactive delirium in 9 ICUsincluded in final analysis
- Participants
- 151 adults
- Comparison
- Dexmedetomidine vs placebo continuous IV infusion for at least 36 h
- Primary endpoint
- Joint modelling of agitation duration (RASS +1 or higher), delirium duration, or need for intubation and deep sedation
Methodological detailsmulticentre, double-blind, placebo-controlled, two-arm, investigator-initiated, Enrollment December 2017 to February 2022; final follow-up February 2023
- Multicentre
- Double-blind
- Placebo-controlled
- Two-arm
- Investigator-initiated
- Enrollment December 2017 to February 2022; final follow-up February 2023
Primary result
As reported in the abstract
Between-group difference in the primary outcome statistically significant
−30 points
median difference, −30 points; 95% CI, - 49 to - 12p = 0.001
Secondary outcomes
Agitation duration · spread kind not named in abstract
absolute difference (hours) - 1.0 (- 2.0 to - 0.1)
| Outcome | ES (95% CI) | P value |
|---|---|---|
| Agitation durationSpread kind not named in abstract | - 0.60 (−0.92 to −0.27) | P = 0.001 |
Other key secondary outcomes (complications, ICU LOS, death)
- Similar between groups
Safety
Complications (e.g. bradycardia or hypotension)
- Similar between groups
Original publication
Composed by AI from the published abstract and checked against it. How Briefs are made →