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

• Status: Recruiting
• Trial end date: 2022-03-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Treatments: Dexmedetomidine

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