Status:
COMPLETED
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Pharmacokinetics
Sedation
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.
Eligibility Criteria
Inclusion
- Written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening
- Patients sedated and ventilated in ICU for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician
- Prescribed light to moderate sedation (target RASS = 0 to -3)
Exclusion
- Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury
- Uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(MAP) \< 55 mmHg despite vasopressor and inotrope therapy)
- Heart rate (HR) \< 50 beats/min for longer than 5 min between screening and starting study treatment
- Atrioventricular (AV)-conduction block II-III (unless pacemaker installed)
- Severe hepatic impairment (e.g. bilirubin \> 101 μmol/L)
- Need for continuous muscle relaxation
- Any condition which would significantly interfere with the collection of study data
- Burn injuries or other conditions requiring regular anesthesia or surgery
- Use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine)
- Known allergy to dexmedetomidine or any excipients of the study treatment
- Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis
- Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy)
- Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome)
- Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00747721
Start Date
September 1 2008
End Date
February 1 2009
Last Update
April 21 2009
Active Locations (1)
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1
Turku University Hospital
Turku, Finland