Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

Pharmacokinetics Clinical Trial

— DEX PK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00747721
• Other study ID #: 3005016
• Secondary ID: EUDRACT: 2008-00
• Status: Completed
• Phase: Phase 1
• First received: September 4, 2008
• Last updated: April 20, 2009
• Start date: September 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2009
• Source: Orion Corporation, Orion Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Pharmacokinetics
• Sedation

Intervention

Drug:
• Dexmedetomidine
2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic variables.		From start of treatment to 48 hr follow-up.	No