The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.

Abdominal Aneurysm Clinical Trial

Official title:

The Effect of Anesthesia on Potential CSF and Serum Markers of Alzheimer's Disease.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01772537
• Other study ID #: NA_00067716
• Secondary ID: 5KL2RR025006
• Status: Terminated
• Phase: N/A
• First received: January 17, 2013
• Last updated: July 25, 2016
• Start date: May 2012
• Est. completion date: February 2014

Study information

• Verified date: July 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: The Johns Hopkins University Institutional Review Board
• Study type: Interventional

Clinical Trial 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 we 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. We will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)

Related Conditions & MeSH terms

• Abdominal Aneurysm
• Aneurysm
• Aortic Aneurysm, Abdominal
• Open Thoracoabdominal Aneurysm Repair
• Thoracoabdominal Aneurysm Repair With Cardiopulmonary Bypass
• Thoracoabdominal Aneurysm Stent

Intervention

Drug:
• Propofol
Intravenous anesthetic
• isoflurane

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Serum inflammatory markers		48 months	No
Primary	Changes in CSF levels of tau and amyloid		48 months	No
Secondary	Delirium and cognitive change		48 months	No