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NCT Number: NCT02684500

Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study

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.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health

Gainesville, Florida, 32610-3003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

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: EDGE Ultrasound System

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2016
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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