Dexmedetomidine vs. clonidine in delirious intensive care patients: a randomised open-label trial

Phase 4

Completed

• Conditions: confusion; Delirium; 10012221

• Registration Number: NL-OMON38662
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

- age > 18
- no response on treatment with haloperidol (max. dose till 3x5mg)
- positive score CAM-ICU

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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Duration of treatment with the alpha2-agonist in days (intervals of 6 hours)<br /><br>untill the first negative CAM-ICU score of the three following days with a<br /><br>negative CAM-ICU score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- RASS score while treated with the alpha2-agonist<br /><br>- total number of days till extubation after start alpha2-agonist (in case the<br /><br>patients are mechanical ventilated)<br /><br>- total number of days till discharge intensive care unit<br /><br>- total of 'delirium-free' days (intervals of 6 hours)<br /><br>- total duration of the delirium episode (intervals of 6 hours) (end of<br /><br>delirium defined as three successive days of negative CAM-ICU scores)</p><br>