Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT03317067
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03317067
Study Brief:
Protocol Section:
NCT03317067