Status:
COMPLETED
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Delirium
Agitation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients
Detailed Description
Delirium during intensive care unit (ICU) stay is frequent and associated with significant morbidity, mortality and healthcare related costs. International guidelines suggest its prevention. However, ...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT03317067
Start Date
December 21 2017
End Date
February 23 2023
Last Update
February 24 2023
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003