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Clinical Trials/NCT02684500
NCT02684500CompletedNot Applicable

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

University of Florida1 site in 1 country14 target enrollmentStarted: April 11, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Change between baseline and 21 days of abdominal ultrasound measurement of the doppler flow velocity in the superior mesenteric artery

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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 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

Secondary Outcomes

  • Number of participants with non-occlusive mesenteric ischemia (NOMI)(Change from baseline up to 21 days)
  • Number of participants with non occlusive bowel necrosis (NOBN)(Change from baseline up to 21 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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