Clinical trial NCT01772537: The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.
Official title: The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thoracic Aneurysm
Aneurysm Stent
Cardiopulmonary Bypass
Abdominal Aneurysm
Keywords: thoracoabdominal
aneurysm
open
stent
cardiopulmonary
abdominal
bypass
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
First posted: 2013-01-21
Enrollment: 14
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The effect of anesthetic agents on changes in these proteins in humans is not well characterized, but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients and showed a significant increase in tau levels after exposure to anesthetics. In this study the investigators propose to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.


Eligibility criteria: Inclusion Criteria:

* age 21-100 years of age
* Patients presenting for surgical repair of a thoracoabdominal aneurysm
* Insertion of a CSF spinal drain for clinically indicated reason

Exclusion Criteria:

* Patients with pre-existing delirium
* Inability to speak and understand English
* Severe hearing impairment, resulting in inability to converse
* Pregnancy. Pregnancy status will be assessed using a serum pregnancy test during preoperative evaluation as part of the standard of care.

Primary outcomes:
measure: Changes in Cerebrospinal Fluid (CSF) Levels of Tau
timeFrame: From insertion of spinal drain until removal
measure: Changes in CSF Levels of Amyloid
timeFrame: From insertion of spinal drain until removal
Secondary outcomes:
measure: Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)
timeFrame: Immediately after surgery and at 3 and 12 months post-op
Other outcomes:
measure: Serum Inflammatory Markers
timeFrame: From the start of the surgery to 24 hours post-op
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Charles Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: