The effect of the medications dexmedetomidine and clonidine on delirium (confused) patients of the intensive care unit.

• Conditions: (ICU- associated) Delirium; MedDRA version: 16.0Level: LLTClassification code 10012226Term: Delirium, cause unknownSystem Organ Class: 100000004873; MedDRA version: 16.0Level: LLTClassification code 10071315Term: Mixed deliriumSystem Organ Class: 100000004873; MedDRA version: 16.0Level: LLTClassification code 10071313Term: Hypoactive deliriumSystem Organ Class: 100000004873; MedDRA version: 16.0Level: LLTClassification code 10071314Term: Hyperactive deliriumSystem Organ Class: 100000004873; MedDRA version: 16.0Level: LLTClassification code 10012220Term: Delirium due to a general medical conditionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-003547-39-NL
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-17
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified