(ICU- associated) Delirium MedDRA version: 16.0 Level: LLT Classification code 10012226 Term: Delirium, cause unknown System Organ Class: 100000004873 MedDRA version: 16.0 Level: LLT Classification code 10071315 Term: Mixed delirium System Organ Class: 100000004873 MedDRA version: 16.0 Level: LLT Classification code 10071313 Term: Hypoactive delirium System Organ Class: 100000004873 MedDRA version: 16.0 Level: LLT Classification code 10071314 Term: Hyperactive delirium System Organ Class: 10
Conditions
Interventions
Trade Name: Dexdor (dexmedetomidine)
Pharmaceutical Form: Concentrate for solution for infusion
Trade Name: Catapresan (clonidinehydrochloride)
Pharmaceutical Form: Concentrate for solution for infus
Sponsors
Isala Klinieken
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 18 - no response on treatment with haloperidol (max. dose till 3x5mg) - positive score CAM-ICU Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - history of epilepsy, Parkinson's disease, hypokinetic rigid syndrome, or Lewy body dementia - treatment with antipsychotic drugs - pregnancy or breastfeeding - CVA < 6months - hypotension (< 90mmHg) - bradycardia (<50/min) - MAP < 60mmHg - comatose patients (RASS -4 or -5) - recent myocardial infarction of severe coronal insufficiency - 2nd of 3rd degree AV-block or sicksinussyndrome - known allergic reaction on clonidine of dexmedetomidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The effects of sedation with clonidine or dexmedetomidine on the duration of haloperidol-resistent delirium in intensive care patients;Secondary Objective: The effect of treatment with clonidine or dexmedetomidine on 1. the duration till extubation in case patients are mechanical ventilated 2. the duration till discharge of the ICU 3. the duration till reaching the aiming level of sedation (RASS0) 4. insight in cost-effectiveness of the medications.;Primary end point(s): Total number of treatment hours with the alpha2-agonist untill a negative CAM-ICU score for three successive days.;Timepoint(s) of evaluation of this end point: After 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - RASS score while treated with the alpha2-agonist - total number of days till extubation after start alpha2-agonist (in case the patients are mechanical ventilated) - total number of days till discharge intensive care unit;Timepoint(s) of evaluation of this end point: After 12 weeks | — |
Countries
Netherlands
Contacts
Public Contactafd. wetenschappelijk onderzoek
Isala Klinieken / Isala Academie
Outcome results
None listed