Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orion Corporation, Orion Pharma
• Treatments: Dexmedetomidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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• Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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)