Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study

Completed

• Conditions: Intracranial Aneurysm
• Interventions: Device: Ultrasound

• Registration Number: NCT02684500
• Lead Sponsor: University of Florida

Brief 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.

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 Timeline

• Study First Submitted: 2016-02-08
• Study First Submitted QC: 2016-02-12
• Study First Posted: 2016-02-18
• Study Start: 2016-04-11
• Primary Completion: 2016-06-30
• Study Completion: 2016-06-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Patient diagnosed with aSAH

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
aneurysmal subarachnoid hemorrhage	Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Change between baseline and 21 days of abdominal ultrasound measurement of the doppler flow velocity in the superior mesenteric artery	Change from baseline up to 21 days
Change between baseline and 21 days of abdominal ultrasound measurement of the diameter in the superior mesenteric artery	Change from baseline up to 21 days

Secondary Outcome Measures

Name	Time	Method
Number of participants with non-occlusive mesenteric ischemia (NOMI)	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).
Number of participants with non occlusive bowel necrosis (NOBN)	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).

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States