Status:
UNKNOWN
Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients
Lead Sponsor:
Erasme University Hospital
Conditions:
Delirium
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Delirium is one of the most common manifestations of cerebral dysfunction in severely ill patients. The international guidelines for the prevention of delirium in intensive care recommend the daily a...
Detailed Description
Delirium is one of the most common manifestations of cerebral dysfunction in severely ill patients (60 to 80% of ventilated patients), leading not only to short-term complications (prolonged duration ...
Eligibility Criteria
Inclusion
- present agitated delirium, confirmed by the CAM-ICU diagnostic scale
- require mechanical restraint or psychotropic / sedative
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04758936
Start Date
February 1 2021
End Date
February 28 2023
Last Update
February 17 2021
Active Locations (3)
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1
CUB Erasme Hospital ULB
Brussels, Belgium, 1070
2
Civil hospital Marie Curie
Charleroi, Belgium
3
Clinique Saint-Pierre
Ottignies, Belgium