Subarachnoid Hemorrhage, AneurysmalPhase 3NCT01565590
Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
A Phase 3 study testing Dexmedetomidine and propofol in people with Subarachnoid Hemorrhage, Aneurysmal, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Dexmedetomidine and propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jul 2015
- Phase
- Phase 3
- 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
- Aneurysmal subarachnoid hemorrhage
- World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
- Surgical intervention with clip or coil
- Placement of cerebrospinal fluid drain (lumbar or ventricular)
- Mechanically ventilated at start of infusion
Who cannot join
- Hemodynamic instability (SBP < 100, HR <60, or on continuous infusion of catecholamines) at screening
- Heart failure class III or IV (New York Heart Association)
- Renal failure (RIFLE classification - see table below)
- Liver failure (serum protein < 3 g/dL and total bilirubin > 5 mg/dL)
- Known or suspected brain death
- Pregnancy
Show all 9Show fewer
- Unable to receive dexmedetomidine within 48 hours of injury and 4 hours of surgery
- Allergy to dexmedetomidine
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Being tested
- Dexmedetomidine, propofol
- Keywords
- aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
0.2-1.5 mcg/kg/hr
propofolDrug
5-80 mcg/kg/min
| Study group | Role | What they receive |
|---|---|---|
| Propofol | Active comparator | Not described Receives: Drug: propofol |
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes between serum and CSF cytokines over 48 hours
Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), glial fibrially acidic protein (GFAP), and malondialdehyde (MDA) as measured in both serum and cerebrospinal fluid (CSF) in 10 patients with aneurysmal subarachnoid hemorrhage (aSAH).
Measured: 0, 24 and 48 hours
Secondary outcomes (6)
Sedative and analgesic medication requirements
Sedation requirements between the two groups will be assessed by comparing total daily dose and average daily fentanyl doses in the 24 hours following surgery. The total number of patients requiring propofol rescue in the dexmedetomidine group and the total daily dose and average daily dose of the propofol used in the dexmedetomidine group will be recorded.
Measured: 2 weeks
Sedation scores (RASS and CAM-ICU)
Measured: 2 weeks
ICU length of stay
Measured: 2 weeks
Hospital length of stay
Measured: 2 weeks
Glasgow Outcome Scores Extended (GOSE) at discharge
Measured: 2 weeks
Incidence of delayed cerebral ischemia (DCI)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Slow enrollment along with new competing studies, investigators decided to stop study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage, AneurysmalStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaun Keegan, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565590
- Sponsor's protocol ID
- 11-11-22-01
- Status last verified
- Jan 2018
- First submitted
- 23 Mar 2012
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Inflammatory Cytokines in Patients With Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01565590
- Acronym / sponsor ID
- 11-11-22-01
- Conditions
- Subarachnoid Hemorrhage, Aneurysmal
- Keywords
- aneurysmal subarachnoid hemorrhage, dexmedetomidine, cytokines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment along with new competing studies, investigators decided to stop study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Mar 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 research is to compare patients with aneurysmal subarachnoid hemorrhage on dexmedetomidine compared to propofol to assess if one group has decreased inflammation. The investigators hypothesis is that the group assigned to receive dexmedetomidine will have a more profound decrease in markers of inflammation over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol | Active comparator | Drug: propofol |
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aneurysmal subarachnoid hemorrhage
- World Federation of Neurological Surgeons (WFNS) grade 4-5 (see table below)
- Surgical intervention with clip or coil
- Placement of cerebrospinal fluid drain (lumbar or ventricular)
- Mechanically ventilated at start of infusion
Key exclusion criteria (9 listed)
- Hemodynamic instability (SBP < 100, HR <60, or on continuous infusion of catecholamines) at screening
- Heart failure class III or IV (New York Heart Association)
- Renal failure (RIFLE classification - see table below)
- Liver failure (serum protein < 3 g/dL and total bilirubin > 5 mg/dL)
- Known or suspected brain death
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 |
|---|---|---|
| Dexmedetomidine0.2-1.5 mcg/kg/hr | Drug | Dexmedetomidine |
| propofol5-80 mcg/kg/min | Drug | Propofol |
Primary outcome
Changes between serum and CSF cytokines over 48 hours
Time frame: 0, 24 and 48 hours
Measure the baseline level (at enrollment) of inflammatory markers tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), glial fibrially acidic protein (GFAP), and malondialdehyde (MDA) as measured in both serum and cerebrospinal fluid (CSF) in 10 patients with aneurysmal subarachnoid hemorrhage (aSAH).
6 secondary outcomes
Sedative and analgesic medication requirements
Time frame: 2 weeks
Sedation scores (RASS and CAM-ICU)
Time frame: 2 weeks
ICU length of stay
Time frame: 2 weeks
Hospital length of stay
Time frame: 2 weeks
Glasgow Outcome Scores Extended (GOSE) at discharge
Time frame: 2 weeks
Incidence of delayed cerebral ischemia (DCI)
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: Slow enrollment along with new competing studies, investigators decided to stop study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
Related trials for Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine and propofol in people with Subarachnoid Hemorrhage, Aneurysmal, run by University of Cincinnati at 1 site in United States.
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 5 inclusion and 9 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: stopped early, as of the sponsor's last update on 1 Feb 2018. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Slow enrollment along with new competing studies, investigators decided to stop study). Results are not available in the source record.
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?
Changes between serum and CSF cytokines over 48 hours (time frame: 0, 24 and 48 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 1 Feb 2018.