Clinical trial NCT00747721: Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
Official title: Pharmacokinetics of Intravenous Dexmedetomidine for Prolonged Infusion in Critically Ill, Ventilated Patients in Intensive Care Unit; an Open, Non-Randomised, Single Centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Sedation
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-09-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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* Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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

Primary outcomes:
measure: Pharmacokinetic variables.
timeFrame: From start of treatment to 48 hr follow-up.
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Timo Iirola
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iirola T, Aantaa R, Laitio R, Kentala E, Lahtinen M, Wighton A, Garratt C, Ahtola-Satila T, Olkkola KT. Pharmacokinetics of prolonged infusion of high-dose dexmedetomidine in critically ill patients. Crit Care. 2011;15(5):R257. doi: 10.1186/cc10518. Epub 2011 Oct 26.