Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study

Intracranial Aneurysm Clinical Trial

Official title:

Evaluation of Superior Mesenteric Artery Diameter and Flow in Aneurysmal Subarachnoid Hemorrhage Patients Undergoing Hypertensive Therapy for Cerebral Artery Vasospasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02684500
• Other study ID #: IRB201500830
• Status: Completed
• Start date: April 11, 2016
• Est. completion date: June 30, 2016

Study information

• Verified date: March 2020
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Hemorrhage
• Intracranial Aneurysm
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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).	Change from baseline up to 21 days
Secondary	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).	Change from baseline up to 21 days