Skip to main content
OpenTrials
Completed

NCT Number: NCT00787020

Ventriculostomies in SAH: ICP Open or Not?

The purpose of this study is explore how cerebrospinal fluid (CSF) drainage impacts outcomes for patients diagnosed with subarachnoid hemorrhage (SAH). This is a non-randomized observational study of two physician-prescribed approaches to managing intracranial pressure monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have intracranial pressure (ICP) monitoring in situ. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University

Durham, North Carolina, 27710, United States

About this study

There are no interventions specific to this observational study. The nurses and physicians who care for subjects in the study are already competent in the care and management of patients with subarachnoid hemorrhage (SAH) and intracranial pressure (ICP) monitoring as a requirement of their current employment at Duke University. Patients with confirmed diagnosis of subarachnoid hemorrhage requiring ICP and CSF management will be admitted to the 16 bed Neurocritical Care Unit (NCCU) at Duke Hospital. After admission procedures and a baseline neurologic assessment are complete, the charge nurse or NCCU fellow will notify an investigator of subjects meeting inclusion criteria. The investigator or research coordinator for this project will complete a review preparatory to research (RPR) to ensure no exclusion criteria are present and once subject appropriateness has been confirmed patients and their families will be introduced to the investigator for the purpose of obtaining informed consent. The subject's legally authorized representative (LAR) will be informed of the study's purpose, risks and benefits, and the rights of research subjects.

Data will be collected that reflects the duration of the patient's hospitalization at Duke University through chart abstraction. The study period will be defined as admission to discharge. The attending physician has, and will continue to, determine the appropriateness of the duration of ICP monitoring, NCCU discharge criteria and hospital discharge criteria. Chart abstraction will be completed daily to obtain the ICP values and CSF volumes during that period of time for which the patient has a ventriculostomy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of subarachnoid hemorrhage
  • Age 18 years or older
  • Ventriculostomy in situ

Exclusion criteria

  • Prisoners
  • Glasgow coma score = 3

Treatment and study plan

Primary outcomes

  1. Cerebral Artery Vasospasm

    Time frame: 14 days

    Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.

Secondary outcomes

  1. External Ventricular Drain (EVD) Complications

    Time frame: 14 Days

    External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.

  2. Cerebrospinal Fluid (CSF) Output Per Day

    Time frame: 14 Days

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: VISION

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Nov 7, 2008
Registry last updated
Nov 3, 2015

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.

Published trials that share one or more normalized conditions with this study.