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

This study is currently recruiting participants.
Verified January 2013 by Johns Hopkins University
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Charles Brown, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01772537
First received: January 17, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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.


Condition Intervention
Open Thoracoabdominal Aneurysm Repair
Thoracoabdominal Aneursym Stent
Thoracoabdominal Aneursym Repair With Cardiopulmonary Bypass
Abdominal Aneurysm
 Drug: Propofol
Drug: isoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Official Title: The Effect of Anesthesia on Potential CSF and Serum Markers of Alzheimer's Disease.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Changes in CSF levels of tau and amyloid [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Delirium and cognitive change [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Serum inflammatory markers [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propofol
Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.
 Drug: Propofol
Intravenous anesthetic
Active Comparator: Isoflurane
standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
 Drug: isoflurane

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 21-100 years of age
  • Patients presenting for surgical repair of a thoracoabdominal aneursym
  • 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 inablility to converse
  • Pregnancy. Pregnancy status will be assesed using a serum pregnancy test during preoperative evaluation as part of the standard of care.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01772537

Contacts
Contact: Charles Brown, MD 410-955-0994 cbrown12@jhmi.edu
Contact: Mirinda Anderson White, RN 410-955-6488 mander47@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charles Brown, MD     410-955-0994     cbrown12@jhmi.edu    
Contact: Mirinda Anderson White, RN     410-955-6488     mander47@jhmi.edu    
Sub-Investigator: Ahbay Moghekar, M.B.B.S            
Sub-Investigator: James Black, MD            
Sponsors and Collaborators
Johns Hopkins University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Charles Brown, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Charles Brown, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01772537     History of Changes
Other Study ID Numbers: NA_00067716, 5KL2RR025006
Study First Received: January 17, 2013
Last Updated: January 17, 2013
Health Authority: United States: The Johns Hopkins University Institutional Review Board

Keywords provided by Johns Hopkins University:
thoracoabdominal
aneurysm
open
stent
 cardiopulmonary
abdominal
bypass

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm
Aortic Diseases
Anesthetics
Isoflurane
Propofol
 Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Inhalation
Anesthetics, General
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 22, 2013