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

This study has been terminated.
(The data did not show clear results)
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01772537
First received: January 17, 2013
Last updated: March 2, 2017
Last verified: March 2017
  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 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.

Condition Intervention
Thoracic Aneurysm Aneurysm Stent Cardiopulmonary Bypass Abdominal Aneurysm Drug: Propofol Drug: isoflurane

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Other
Official Title: The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Changes in Cerebrospinal Fluid (CSF) Levels of Tau [ Time Frame: From insertion of spinal drain until removal ]

    Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.


  • Changes in CSF Levels of Amyloid [ Time Frame: From insertion of spinal drain until removal ]
    Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.


Secondary Outcome Measures:
  • Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM) [ Time Frame: Immediately after surgery and at 3 and 12 months post-op ]
    Delirium was measured using the Confusion Assessment Method and the Confusion Assessment Method- Intensive Care Unit (CAM-ICU) based upon post-operative location of patient. The patients were divided into to two groups, patients that had an open thoracoabdominal aneurysm repair versus patients that had stenting of their aneurysms. Patients that had stenting of their aneurysms were also randomized to receive either Propofol or Isoflurane as for their anesthetic.


Other Outcome Measures:
  • Serum Inflammatory Markers [ Time Frame: From the start of the surgery to 24 hours post-op ]
    Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured


Enrollment: 14
Study Start Date: May 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Open repair of thoracoabdominal aneurysms
These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only.
Active Comparator: Stent graft repair of thoracoabdominal aneurysms isoflurane
These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic.
Drug: isoflurane
Active Comparator: Stent graft repair of thoracoabdominal aneurysms propofol
These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic.
Drug: Propofol
Intravenous anesthetic

  Eligibility

Ages Eligible for Study:   21 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01772537

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Charles Brown, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01772537     History of Changes
Other Study ID Numbers: NA_00067716
5KL2RR025006 ( U.S. NIH Grant/Contract )
Study First Received: January 17, 2013
Results First Received: September 20, 2016
Last Updated: March 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 26, 2017