The effects and optimum dosing of clonidine in critically ill ventilated patients

Phase 1

• Conditions: Delirium The pharmacokinetic and dynamic properties of intravenous clonidine in critical ill mechanically treated patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-001699-23-NL
• Lead Sponsor: Deventer Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-30
• Last Update Posted: 5 June 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

•at least 18 years of age
•intubated
•sedated
at the start of the study. Because of the high incidence of delirium on the ICU in all age categories, all age groups > 18 years will be included.

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

•Severe neurotrauma,
•Severe dementia (living in a nursing home)
•Inability to speak Dutch or English, which is one of the causes of not being able to use the CAM-ICU.
•The use of clonidine during the 96 hours before the start of the study.
•Bradycardia (<50/min)
•Severe hypotension (MAP < 65 after volume resuscitation and vasopressors)
•Pregnancy and lactation (pregnancy test are routinely performed in premenopausal women on the ICU).
•Epilepsy
•Known clonidine intolerance
•Liver cirrhosis (Child Pugh class C)
•Recent and acute myocardial infarction
•Severe heart failure (LVEF < 30%)
•Second or third degree AV-block without a permanent pacemaker
•Expected transfer to another hospital.

Study & Design

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