Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients (Clodex)
Delirium, Critical Illness
About this trial
This is an interventional treatment trial for Delirium focused on measuring Clonidine, Dexmedetomidine, Delirium, intensive care
Eligibility Criteria
Inclusion Criteria:
- present agitated delirium, confirmed by the CAM-ICU diagnostic scale
- require mechanical restraint or psychotropic / sedative
Exclusion Criteria:
- Acute neurological central or medullary problems (vascular, traumatic, infectious, tumoral causes)
- Severe hepatic insufficiency (Child C cirrhosis)
- Severe renal insufficiency (creatinine clearance <30ml / min) or renal replacement therapy
- Bradycardia <60 / min
- 2nd or 3rd degree atrioventricular block (unless placed pacemaker)
- Hemodynamic instability (MAP <60mmHg despite adequate vascular filling and vasopressor treatment).
- Pregnant woman or breastfeeding
- Use of α-2 agonist or antagonist agents within 24 hours of randomization
- Allergy known to one of the α-2 agonists used in the study
- Moribund patient (survival prognosis at limited 24h or therapeutic de-escalation envisaged)
Sites / Locations
- CUB Erasme Hospital ULBRecruiting
- Civil hospital Marie CurieRecruiting
- Clinique Saint-PierreRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Clonidine
Dexmedetomidine
Given that agitated delirium requires rapid medical intervention, α-2 agonist therapy (clonidine) will be administered as soon as possible, The sedative and analgesic treatments will be administered and titrated according to the scales on the usual protocol of the service (evaluation of sedation (NICS) and analgesia (VAS, BPS, BPS-NI). In case of excessive sedation assessed by the scores and administration of combined treatments (α-2 agonist and other sedatives), the reduction of the doses of other sedatives will be preferred over the α-2 agonist treatment. In case of insufficient sedation despite maximal doses of α-2 agonist, other sedatives (choosen by the attending physician) will administered and titrated according to the scales for pain and sedation evaluation.
Given that agitated delirium requires rapid medical intervention, α-2 agonist therapy (dexmedetomidine) will be administered as soon as possible. The α-2 agonist treatment that will be started will depend on the allocation of the previously randomized unit. The sedative and analgesic treatments will be administered and titrated according to the scales on the usual protocol of the service (evaluation of sedation (NICS) and analgesia (VAS, BPS, BPS-NI). In case of excessive sedation assessed by the scores and administration of combined treatments (α-2 agonist and other sedatives), the reduction of the doses of other sedatives will be preferred over the α-2 agonist treatment. In case of insufficient sedation despite maximal doses of α-2 agonist, other sedatives (choosen by the attending physician) will administered and titrated according to the scales for pain and sedation evaluation.