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| ID | Type | Description | Link |
|---|---|---|---|
| 5KL2RR025006 | U.S. NIH Grant/Contract | View source |
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The data did not show clear results
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | Intravenous anesthetic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. . | 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. | From insertion of spinal drain until removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Inflammatory Markers | Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured | From the start of the surgery to 24 hours post-op |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Brown, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stent Graft Repair Propofol | Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic |
| FG001 | Stent Graft Repair 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. isoflurane |
| FG002 | Open Repair | These patient will receive no intervention, just standard of care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stent Graft Repair Propofol | Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic |
| BG001 | Stent Graft Repair Isoflurane |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. . | The data for changes in CSF levels of tau are not available. The study did not have adequate funding to appropriately measure these variables. | Posted | From insertion of spinal drain until removal |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stent Graft Repair Propofol | Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol. Propofol: Intravenous anesthetic |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Brown | The Johns Hopkins University | 410-955-0994 | cbrown@jhmi.edu |
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| ID | Term |
|---|---|
| D017545 | Aortic Aneurysm, Thoracic |
| D017544 | Aortic Aneurysm, Abdominal |
| D000783 | Aneurysm |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D007530 | Isoflurane |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| isoflurane |
| Drug |
|
| Immediately after surgery and at 3 and 12 months post-op |
standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.
isoflurane
| BG002 | Open Repair | These patients received no intervention, just standard of care. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | 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. | The data for changes in CSF levels of amyloid are not available. The study did not have adequate funding to appropriately measure these variables. | Posted | From insertion of spinal drain until removal |
|
|
| Secondary | 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. | Of the 6 patients that received an open thoracoabdominal aneurysm repair 2 were found to have delirium. Of the 5 subjects that had stenting and received Propofol as their primary anesthetic, 0 were found to have delirium. Of the 3 stenting subjects that received Isoflurane as their primary anesthetic, 1 were found to have delirium. | Posted | Number | participants | Immediately after surgery and at 3 and 12 months post-op |
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|
|
| Other Pre-specified | Serum Inflammatory Markers | Serum inflammatory markers will be compared per anesthetic group, Propofol versus Isoflurane. A sample of 10 individuals from each group will have biomarkers measured | No data is available for serum inflammatory markers. The study did not have adequate funding to appropriately measure these variables. | Posted | From the start of the surgery to 24 hours post-op |
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Stent Graft Repair 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. isoflurane | 0 | 3 | 0 | 3 |
| EG002 | Open Thoracoabdominal Aneurysm Repair | These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting. | 0 | 6 | 0 | 6 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D008738 | Methyl Ethers |
| D004987 | Ethers |