Pharmacokinetics and Clinical Effects of Escalating Doses of Clonidine in ICU Patients

• Status: Completed
• Trial end date: 2018-04-05
• Target enrollment: 0
• Participant gender: All

Summary

This study is developed for assessing the pharmacodynamic and pharmacokinetic properties of intravenous (IV) clonidine in critically ill patients on the ICU, and to estimate the optimal dosing strategy for IV clonidine.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deventer Ziekenhuis
• Treatments: Clonidine

Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must be:

• 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

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 atrioventricular (AV)-block without a permanent pacemaker

• Expected transfer to another hospital.