Thoracic AneurysmNCT01772537
The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm.
A study testing Propofol and isoflurane in people with Thoracic Aneurysm and Aneurysm Stent, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Thoracic Aneurysm, Aneurysm Stent, Cardiopulmonary Bypass
- What is being tested?
- Propofol and isoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.
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.
- Being tested
- Propofol, isoflurane
- Keywords
- thoracoabdominal, aneurysm, open, stent, cardiopulmonary, abdominal, bypass
- Medical subject headings
- Aortic Aneurysm, Thoracic, Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Intravenous anesthetic
isofluraneDrug
| Study group | Role | What they receive |
|---|---|---|
| Open repair of thoracoabdominal aneurysms | No intervention | These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only. |
| Stent graft repair of thoracoabdominal aneurysms isoflurane | Active comparator | These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic. Receives: Drug: isoflurane |
| Stent graft repair of thoracoabdominal aneurysms propofol | Active comparator | These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cerebrospinal Fluid (CSF) Levels of Tau
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.
.
Measured: From insertion of spinal drain until removal
Changes in CSF Levels of Amyloid
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.
Measured: From insertion of spinal drain until removal
Secondary outcomes (1)
Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)
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.
Measured: Immediately after surgery and at 3 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: The data did not show clear results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thoracic AneurysmStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Responsible party
- Sponsor
- Investigators
- Charles Brown, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772537
- Sponsor's protocol ID
- NA_00067716
- Other IDs
- 5KL2RR025006
- Status last verified
- Mar 2017
- First submitted
- 17 Jan 2013
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT01772537
- Acronym / sponsor ID
- NA_00067716
- Keywords
- thoracoabdominal, aneurysm, open, stent, cardiopulmonary, abdominal, bypass
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The data did not show clear results
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Center for Research Resources (NCRR)
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Posted 24 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open repair of thoracoabdominal aneurysms | No intervention | –These will be patients undergoing an open repair of thoracoabdominal aneurysms with or without cardiopulmonary bypass. The will be observational only. |
| Stent graft repair of thoracoabdominal aneurysms isoflurane | Active comparator | Drug: isofluraneThese patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic. |
| Stent graft repair of thoracoabdominal aneurysms propofol | Active comparator | Drug: PropofolThese patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropofolIntravenous anesthetic | Drug | Stent graft repair of thoracoabdominal aneurysms propofol |
| isoflurane | Drug | Stent graft repair of thoracoabdominal aneurysms isoflurane |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Brown, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol and isoflurane in people with Thoracic Aneurysm and Aneurysm Stent, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cerebrospinal Fluid (CSF) Levels of Tau (time frame: From insertion of spinal drain until removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.