Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial) (NCT03317067) | Clinical Trial Compass
CompletedPhase 3
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
France151 participantsStarted 2017-12-21
Plain-language summary
The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • Age \> 18 years
* Patient hospitalized in an ICU
* Presenting a productive delirium according to the following criteria:
* acute onset (\<2h) and fluctuating course during the same day
* alteration of cognitive functions: disorganization of thought (delirium of persecution, inability to reason logically), abnormal perceptions (hallucinations), memory impairments, temporal disorientation, non- or misrecognitions, difficulties in naming objects or writing)
* in whom a simple cropping and non-medicated therapeutics are not sufficient to allow symptoms' resolution for few hours
* CAM-ICU positive AND a RASS \> +1
* Non-intubated or extubated (\> 24h)
* No contraindication of dexmedetomidine or haloperidol uses
Exclusion Criteria:
* • Age \<18 years
* Administration of dexmedetomidine and/or clonidine during the 72 hours before inclusion
* Contraindication to the use of Dexmedetomidine, clonidine or haloperidol (history of allergy, Parkinson's disease, oro-pharyngeal dysfunction, arterial hypotension or bradycardia, QTc interval prolongation, and hepatic or renal dysfunction), as mentioned in the Summaries of Product Characteristics
* Neuropsychiatric pathology judged by the investigator as a potential source of bias (in particular: active drug addiction, psychosis...)
* Parturient or breast-feeding woman
* Protected major (guardianship)
* Patient's or relative's refusal to participate
What they're measuring
1
duration of agitation (in hours), defined by a RASS ≥ +1
Timeframe: at day 1
2
duration of delirium (in days), defined by a positive CAM-ICU
Timeframe: at day 1
3
delay (in hours) between inclusion and intubation requirement to control delirium with deep sedation and mechanical ventilation