Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

NCT00747721 | Completed Phase 1

• 2 other identifiers: 3005016EUDRACT: 2008-001646-10
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic variables.

  From start of treatment to 48 hr follow-up.

Study Arms (1)

1

EXPERIMENTAL

Dexmedetomidine

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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• Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis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

Sponsors & Collaborators

• Orion Corporation, Orion Pharma: lead

Study Sites (1)

Turku University Hospital

Turku, Finland

Location

Related Publications (1)

• 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.

  PMID: 22030215 DERIVED

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Timo Iirola

  Turku University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 4, 2008
• First Posted: September 5, 2008
• Study Start: September 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 21, 2009

Record last verified: 2009-04

Locations

FI (1)