Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU (DEX PK)

Orion Pharma

Status and phase

Completed

Phase 1

Conditions

Sedation

Pharmacokinetics

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00747721

3005016

EUDRACT: 2008-001646-10

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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