- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02684500
Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study
March 18, 2020 updated by: University of Florida
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.
Study Overview
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 Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Gainesville, Florida, United States, 32610-3003
- UF Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Patient diagnosed with aSAH
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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 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
|
Change from baseline up to 21 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with non-occlusive mesenteric ischemia (NOMI)
Time Frame: Change from baseline up to 21 days
|
Number of participants with non-occlusive mesenteric ischemia (NOMI) undergoing hypertension therapy with vasoactive medications for cerebral arterial vasospasm in aneurysmal subarachnoid hemorrhage (aSAH).
|
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
|
Number of participants with non occlusive bowel necrosis (NOBN) undergoing hypertension therapy with vasoactive medications for cerebral arterial vasospasm in aneurysmal subarachnoid hemorrhage (aSAH).
|
Change from baseline up to 21 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peggy White, MD, University of Florida
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 11, 2016
Primary Completion (Actual)
June 30, 2016
Study Completion (Actual)
June 30, 2016
Study Registration Dates
First Submitted
February 8, 2016
First Submitted That Met QC Criteria
February 12, 2016
First Posted (Estimate)
February 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 19, 2020
Last Update Submitted That Met QC Criteria
March 18, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201500830
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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