Intracranial AneurysmNCT02684500
Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study
An observational study of Intracranial Aneurysm, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine if the diameter and flow of the superior mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive therapy for cerebral artery vasospasm are effected enough to justify withholding enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Intracranial Aneurysm
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2016to 30 Jun 2016
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the neurointensive care unit (NICU).Patients admitted to the neurointensive care unit (NICU) with a diagnosis of aSAH or are diagnosed with aSAH while an inpatient at the NICU at and area hospital.
Who may be able to join
- Patient diagnosed with aSAH
Who cannot join
- Hemodynamic instability
- Already receiving vasopressor therapy
- Non-aneurysmal SAH
- Intracranial hemorrhage of other cause
- Not anticipated to receive hypertensive therapy with vasoactive medications for cerebral vasospasm from SAH or suspected aSAH
- Unable to visualize SMA using ultrasound
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Superior Mesenteric Artery Diameter and Flow in Aneurysmal Subarachnoid Hemorrhage Patients Undergoing Hypertensive Therapy for Cerebral Artery Vasospasm
The purpose of this research study is to determine if the diameter and flow of the superior mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive therapy for cerebral artery vasospasm are effected enough to justify withholding enteral nutrition.
Read the detailed description
Study measurements of the diameter and Doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) in patients undergoing hypertensive therapy for cerebral vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH), to justify the withholding of enteral nutrition.
- Conditions
- Intracranial Aneurysm
- Being tested
- Ultrasound
- Keywords
- aSAH
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Also called EDGE Ultrasound System
Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) for a aneurysmal subarachnoid hemorrhage in subjects undergoing hypertensive therapy for cerebral vasospasm in SAH, to justify the withholding of enteral nutrition. Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between baseline and 21 days of abdominal ultrasound measurement of the diameter in the superior mesenteric artery
Measured: Change from baseline up to 21 days
Change between baseline and 21 days of abdominal ultrasound measurement of the doppler flow velocity in the superior mesenteric artery
Measured: Change from baseline up to 21 days
Secondary outcomes (2)
Number of participants with non-occlusive mesenteric ischemia (NOMI)
Number of participants with non-occlusive mesenteric ischemia (NOMI) undergoing hypertension therapy with vasoactive medications for cerebral arterial vasospasm in aneurysmal subarachnoid hemorrhage (aSAH).
Measured: Change from baseline up to 21 days
Number of participants with non occlusive bowel necrosis (NOBN)
Number of participants with non occlusive bowel necrosis (NOBN) undergoing hypertension therapy with vasoactive medications for cerebral arterial vasospasm in aneurysmal subarachnoid hemorrhage (aSAH).
Measured: Change from baseline up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start11 Apr 2016
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy White, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684500
- Sponsor's protocol ID
- IRB201500830
- Status last verified
- Mar 2020
- First submitted
- 8 Feb 2016
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Superior Mesenteric Artery Diameter and Flow in Aneurysmal Subarachnoid Hemorrhage Patients Undergoing Hypertensive Therapy for Cerebral Artery Vasospasm
- ClinicalTrials.gov ID
- NCT02684500
- Acronym / sponsor ID
- IRB201500830
- Conditions
- Intracranial Aneurysm
- Keywords
- aSAH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 18 Feb 2016 (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 study is to determine if the diameter and flow of the superior mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive therapy for cerebral artery vasospasm are effected enough to justify withholding enteral nutrition.
Detailed description
Study measurements of the diameter and Doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) in patients undergoing hypertensive therapy for cerebral vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH), to justify the withholding of enteral nutrition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aneurysmal subarachnoid hemorrhage | – | Device: UltrasoundStudy measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) for a aneurysmal subarachnoid hemorrhage in subjects undergoing hypertensive therapy for cerebral vasospasm in SAH, to justify the withholding of enteral nutrition. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the neurointensive care unit (NICU).Patients admitted to the neurointensive care unit (NICU) with a diagnosis of aSAH or are diagnosed with aSAH while an inpatient at the NICU at and area hospital.
Key inclusion criteria (1 listed)
- Patient diagnosed with aSAH
Key exclusion criteria (7 listed)
- Hemodynamic instability
- Already receiving vasopressor therapy
- Non-aneurysmal SAH
- Intracranial hemorrhage of other cause
- Not anticipated to receive hypertensive therapy with vasoactive medications for cerebral vasospasm from SAH or suspected aSAH
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 |
|---|---|---|
| UltrasoundAlso: EDGE Ultrasound SystemStudy measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound. | Device | aneurysmal subarachnoid hemorrhage |
Primary outcome
Change between baseline and 21 days of abdominal ultrasound measurement of the diameter in the superior mesenteric artery
Time frame: Change from baseline up to 21 days
Change between baseline and 21 days of abdominal ultrasound measurement of the doppler flow velocity in the superior mesenteric artery
Time frame: Change from baseline up to 21 days
2 secondary outcomes
Number of participants with non-occlusive mesenteric ischemia (NOMI)
Time frame: Change from baseline up to 21 days
Number of participants with non occlusive bowel necrosis (NOBN)
Time frame: Change from baseline up to 21 days
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 19 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Peggy White, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by University of Florida 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 1 inclusion and 7 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 19 Mar 2020. 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.
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 between baseline and 21 days of abdominal ultrasound measurement of the diameter in the superior mesenteric artery (time frame: Change from baseline up to 21 days). The study lists 2 primary outcomes in all. 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 19 Mar 2020.