Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study

NCT ID: NCT02684500

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-11

Study Completion Date

2016-06-30

Brief Summary

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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

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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

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Intracranial Aneurysm

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Ultrasound

Intervention Type DEVICE

Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.

Interventions

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Ultrasound

Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.

Intervention Type DEVICE

Other Intervention Names

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EDGE Ultrasound System

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peggy White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201500830

Identifier Type: -

Identifier Source: org_study_id

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