Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

NCT ID: NCT00747721

Last Updated: 2009-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-02-28

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.

Conditions

Pharmacokinetics; Sedation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

1

Dexmedetomidine

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Dexmedetomidine

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

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Orion Corporation, Orion Pharma

Principal Investigators

Timo Iirola

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Turku University Hospital

Turku, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 22030215 (View on PubMed)

Other Identifiers

EUDRACT: 2008-001646-10

Identifier Type: -

Identifier Source: secondary_id

3005016

Identifier Type: -

Identifier Source: org_study_id