Subarachnoid HemorrhagePhase 1/2NCT01664520
Dexmedetomidine and Subarachnoid Haemorrhage
A Phase 1/2 study testing Dexmedetomidine infusion in people with Subarachnoid Hemorrhage and Aneurysm, run by Turku University Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysm
- What is being tested?
- Dexmedetomidine infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2013to 30 Dec 2016
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aneurysmal SAH
- Aneurysm treated with coil(s) or clip(s)
- Age 18-80 years
- Written informed consent from the next of kin
Who cannot join
- Pregnancy
- Nursing woman
- Sick sinus syndrome
- Carotid stenosis
- Heart rate less than 50 beats / minute
- Mean arterial pressure less than 50 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients
The purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients.
Read the detailed description
Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia without respiratory depression. These effects, as well as neuroprotective properties in experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade SAH patients are treated in intensive care units (ICU). These patients are sedated often with propofol. However, to assess the patient's neurology, the propofol sedation must be stopped and the wakening of the patient may take time. Dexmedetomidine would be more advantageous, allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral autoregulation are unknown in SAH patients.
15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled in to the study.
- Conditions
- Subarachnoid Hemorrhage, Aneurysm
- Being tested
- Dexmedetomidine infusion
- Keywords
- Subarachnoid hemorrhage, Dexmedetomidine, Autoregulation, Intracranial pressure, Cerebral oxygenation
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine infusionDrug
Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.
Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomine infusion | Experimental | Not described Receives: Drug: Dexmedetomidine infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in autoregulation, ICP and cerebral oxygenation
Autoregulation is assessed using transcranial doppler (TCD) and ICP amplitude analysis. ICP and cerebral oxygenation are part of standard multimodal monitoring and these are continuously monitored and recorded.
Measured: 2, 4 and 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startJun 2013
- Primary completion30 Nov 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Orion Corporation, Orion Pharma
- Responsible party
- Principal investigator, Riikka Takala, Turku University Hospital
- Investigators
- Riikka SK Takala, MD PhD, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664520
- Sponsor's protocol ID
- Turku University Hospital
- Other IDs
- 2012-000068-11, KLNRO 45/2012
- Status last verified
- Feb 2017
- First submitted
- 4 Aug 2012
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients
- ClinicalTrials.gov ID
- NCT01664520
- Acronym / sponsor ID
- Turku University Hospital
- Conditions
- Subarachnoid Hemorrhage, Aneurysm
- Keywords
- Subarachnoid hemorrhage, Dexmedetomidine, Autoregulation, Intracranial pressure, Cerebral oxygenation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Orion Corporation, Orion Pharma
- Study start
- Jun 2013
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 14 Aug 2012 (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 purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients.
Detailed description
Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia without respiratory depression. These effects, as well as neuroprotective properties in experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade SAH patients are treated in intensive care units (ICU). These patients are sedated often with propofol. However, to assess the patient's neurology, the propofol sedation must be stopped and the wakening of the patient may take time. Dexmedetomidine would be more advantageous, allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral autoregulation are unknown in SAH patients.
15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled in to the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomine infusion | Experimental | Drug: Dexmedetomidine infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aneurysmal SAH
- Aneurysm treated with coil(s) or clip(s)
- Age 18-80 years
- Written informed consent from the next of kin
Key exclusion criteria (6 listed)
- Pregnancy
- Nursing woman
- Sick sinus syndrome
- Carotid stenosis
- Heart rate less than 50 beats / minute
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 |
|---|---|---|
| Dexmedetomidine infusionBoth static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again. Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments | Drug | Dexmedetomine infusion |
Primary outcome
Change in autoregulation, ICP and cerebral oxygenation
Time frame: 2, 4 and 6 hours
Autoregulation is assessed using transcranial doppler (TCD) and ICP amplitude analysis. ICP and cerebral oxygenation are part of standard multimodal monitoring and these are continuously monitored and recorded.
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 6 Feb 2017.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
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.
Riikka SK Takala, MD PhD study director
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 1/2 study testing Dexmedetomidine infusion in people with Subarachnoid Hemorrhage and Aneurysm, run by Turku University Hospital 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 4 inclusion and 6 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 6 Feb 2017. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in autoregulation, ICP and cerebral oxygenation (time frame: 2, 4 and 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2017.