PharmacokineticsPhase 1DEX PKNCT00747721
Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU
A Phase 1 study testing Dexmedetomidine in people with Pharmacokinetics and Sedation, run by Orion Corporation, Orion Pharma at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacokinetics, Sedation
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Feb 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dexmedetomidine Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic variables.
Measured: From start of treatment to 48 hr follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timo Iirola, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747721
- Sponsor's protocol ID
- 3005016
- Other IDs
- EUDRACT: 2008-001646-10
- Acronym
- DEX PK
- Status last verified
- Apr 2009
- First submitted
- 4 Sep 2008
- Last updated
- 21 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22030215
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00747721
- Acronym / sponsor ID
- DEX PK / 3005016
- Conditions
- Pharmacokinetics, Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DexmedetomidineDexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy. | Drug | 1 |
Primary outcome
Pharmacokinetic variables.
Time frame: From start of treatment to 48 hr follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2009.
- Derived from this study: PubMed 22030215Iirola 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.
Related trials for Pharmacokinetics
RecruitingPhase 1
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
Healthy Volunteer, Pharmacokinetics
RecruitingPhase 1
Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
NAD+ Metabolism, Pharmacokinetics
Not yet recruitingObservational study
Pharmacokinetics and Optimal Dosing of Levetiracetam in Critically Ill Patients Undergoing Continuous Renal Replacement Therapy
Continuous Renal Replacement Therapy (CRRT), Pharmacokinetics
RecruitingPhase 1
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
Cetuximab, Bioequivalence
RecruitingPhase 1
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
Healthy Volunteers, Safety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timo Iirola principal investigator
Turku University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine in people with Pharmacokinetics and Sedation, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic variables. (time frame: From start of treatment to 48 hr follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00747721, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2009; AzTrials last refreshed its copy on 8 Nov 2026.