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| ID | Type | Description | Link |
|---|---|---|---|
| K76AG057020 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to conduct a pilot trial to determine the feasibility, safety, and potential efficacy of targeting mean arterial blood pressure (MAP) within the limits of cerebral autoregulation during surgery compared with usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood pressure managed by cerebral autoregulation | Experimental | In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation. |
|
| Standard of care blood pressure management | Active Comparator | In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure management according to cerebral autoregulation | Other | Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Arterial Pressure Outside Limits of Cerebral Autoregulation | Extent (mmHg * hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure. | Intraoperative, up to 5 hours |
| Estimated Blood Loss | Blood loss during surgery (mL). | Intraoperative, up to 5 hours |
| Number of Participants With New Myocardial Infarction After Surgery | Clinically diagnosed new myocardial infarction after surgery as a measure of incidence. | In the hospital after surgery, up to 2 weeks |
| Number of Participants With New Stroke After Surgery | Clinically diagnosed new stroke after surgery as a measure of incidence. | In the hospital after surgery, up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Develop Delirium After Surgery | Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU. | In the hospital during the first 3 days after surgery |
| Change in General Cognitive Function as Assessed by the Short Blessed Test |
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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 |
|---|---|---|---|---|---|---|
| The Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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2 patients were excluded during secondary screen before randomization
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Pressure Managed by Cerebral Autoregulation | In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation. |
| FG001 | Standard of Care Blood Pressure Management | In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
2 patients were excluded prior to randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Pressure Managed by Cerebral Autoregulation | In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Arterial Pressure Outside Limits of Cerebral Autoregulation | Extent (mmHg * hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure. | Signals did not work with one participant and no data was collected. | Posted | Mean | Standard Deviation | mmHg * hours | Intraoperative, up to 5 hours |
|
Up to 13-months
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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 | Blood Pressure Managed by Cerebral Autoregulation | In this arm cerebral autoregulation monitoring will be used to determine the lower and upper limits of cerebral autoregulation. Monitoring will continue throughout the surgery. Blood pressure management will be maintained to be within the limits of cerebral autoregulation. Blood pressure management according to cerebral autoregulation: Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles Brown, MD PhD | Stanford University | 6504983512 | chbrown@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 8, 2023 | Jun 27, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 22, 2022 | Jun 27, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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| Blood pressure management according to usual care | Other | Intraoperative blood pressure will be targeted based on usual care. |
|
Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. |
| Approximately 60, 180, and 365 Days after Surgery |
| Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test | Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance. | Approximately 60, 180, and 365 Days after Surgery |
| Dementia Screening as Assessed by the AD8 Test | Will be assessed via the Eight-item Interview to Differentiate Aging and Dementia Test (AD8). Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia | 365 Days after Surgery |
| Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0 | Will be assessed via the World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Scores range from 0-100 with 0 indicating no disability and 100 indicating severe disability. | Approximately 60, 180, and 365 Days after Surgery |
| Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire | Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment. | Approximately 60, 180, and 365 Days after Surgery |
| Change in Ability to Ambulate Without Human Assistance | Inability to walk more than 10 feet without human assistance. | Approximately 60, 180, and 365 Days after Surgery |
| still in study followup |
|
| Standard of Care Blood Pressure Management |
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Chronic Obstructive Pulmonary Disorder (COPD) | Count of Participants | Participants | No |
|
| Diabetes Mellitus | Count of Participants | Participants |
|
| Coronary Artery Disease | Count of Participants | Participants |
|
| Cardiac Arrhythmia | Count of Participants | Participants |
|
| Past Stroke or Transient Ischemic Attack | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Hemoglobin (g/dl) | Mean | Standard Deviation | (g/dl) |
|
In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. |
|
|
|
| Primary | Estimated Blood Loss | Blood loss during surgery (mL). | Posted | Mean | Standard Deviation | mL | Intraoperative, up to 5 hours |
|
|
|
|
| Primary | Number of Participants With New Myocardial Infarction After Surgery | Clinically diagnosed new myocardial infarction after surgery as a measure of incidence. | Posted | Count of Participants | Participants | In the hospital after surgery, up to 2 weeks |
|
|
|
|
| Primary | Number of Participants With New Stroke After Surgery | Clinically diagnosed new stroke after surgery as a measure of incidence. | Posted | Count of Participants | Participants | In the hospital after surgery, up to 2 weeks |
|
|
|
|
| Secondary | Number of Participants That Develop Delirium After Surgery | Development of delirium after surgery as diagnosed by the 3-Minute, Diagnostic Interview for Confusion Assessment Method (3D-CAM) or CAM-ICU. | Posted | Count of Participants | Participants | In the hospital during the first 3 days after surgery |
|
|
|
|
| Secondary | Change in General Cognitive Function as Assessed by the Short Blessed Test | Will be assessed via Short Blessed Test. Scores range from 0-28 with 0 indicating no cognitive impairment and 28 indicating severe cognitive impairment. | Not Posted | Approximately 60, 180, and 365 Days after Surgery | Participants |
| Secondary | Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test | Will be assessed via Oral Trail Making Test. The test is timed, and shorter times indicate better performance and longer times indicate worse performance. | Not Posted | Approximately 60, 180, and 365 Days after Surgery | Participants |
| Secondary | Dementia Screening as Assessed by the AD8 Test | Will be assessed via the Eight-item Interview to Differentiate Aging and Dementia Test (AD8). Scores range from 0-8 with 0 indicating no cognitive impairment and 8 indicating severe cognitive impairment consistent with dementia | Not Posted | Jul 2026 | 365 Days after Surgery | Participants |
| Secondary | Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0 | Will be assessed via the World Health Organization (WHO) Disability Assessment Schedule 2.0 (WHO-DAS 2.0). Scores range from 0-100 with 0 indicating no disability and 100 indicating severe disability. | Not Posted | Approximately 60, 180, and 365 Days after Surgery | Participants |
| Secondary | Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire | Score on Instrumental Activities of Daily Living. Scores range from 0-8, with 0 indicating severe impairment and 8 indicating no impairment. | Not Posted | Approximately 60, 180, and 365 Days after Surgery | Participants |
| Secondary | Change in Ability to Ambulate Without Human Assistance | Inability to walk more than 10 feet without human assistance. | Not Posted | Approximately 60, 180, and 365 Days after Surgery | Participants |
| 1 |
| 18 |
| 8 |
| 18 |
| 6 |
| 18 |
| EG001 | Standard of Care Blood Pressure Management | In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. Blood pressure management according to usual care: Intraoperative blood pressure will be targeted based on usual care. | 0 | 7 | 3 | 7 | 5 | 7 |
| Hematuria or UTI | Renal and urinary disorders | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
|
| Sepsis | Infections and infestations | Systematic Assessment |
|
| Emphysema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Stroke | Nervous system disorders | Systematic Assessment |
|
| Bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pneumothorax prolonged | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| low back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Subcutaneous Emphysema | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Delirium | Nervous system disorders | Non-systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Dementia | Nervous system disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
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| D007869 |
| Leg Injuries |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |