Clinical trial NCT00787020: Ventriculostomies in SAH: ICP Open or Not?
Official title: Ventriculostomies in SAH: ICP Open or Not?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subarachnoid Hemorrhage
Keywords: Cerebrospinal Fluid
Ventriculostomy
Subarachnoid hemorrhage
vasospasm
Human Subjects
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subarachnoid hemorrhage

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Prisoners
* Glasgow coma score = 3

Primary outcomes:
measure: Cerebral Artery Vasospasm
timeFrame: 14 days
Secondary outcomes:
measure: External Ventricular Drain (EVD) Complications
timeFrame: 14 Days
measure: Cerebrospinal Fluid (CSF) Output Per Day
timeFrame: 14 Days
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: DaiWai M Olson, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim GS, Amato A, James ML, Britz GW, Zomorodi A, Graffagnino C, Zomorodi M, Olson DM. Continuous and intermittent CSF diversion after subarachnoid hemorrhage: a pilot study. Neurocrit Care. 2011 Feb;14(1):68-72. doi: 10.1007/s12028-010-9401-y.