Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

Phase 1

Completed

• Conditions: Pharmacokinetics; Sedation
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT00747721
• Lead Sponsor: Orion Corporation, Orion Pharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Primary Completion: 2009-01
• Study Completion: 2009-02
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-20
• Last Update Posted: 2009-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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• Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Dexmedetomidine	Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic variables.	From start of treatment to 48 hr follow-up.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Finland