Hip FracturesNCT05308290
Optimizing Cerebral Autoregulation During Surgery
A study testing Blood pressure management according to cerebral autoregulation in people with Hip Fractures and Hip Arthropathy, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Hip Fractures, Hip Arthropathy, Surgery
- What is being tested?
- Blood pressure management according to cerebral autoregulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 30 Jul 2025
- 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 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned hip or knee surgery (either for fracture or elective) or lung surgery
- age ≥60
- ambulatory at baseline
- expected duration of surgery > 90 minutes
Who cannot join
- Planned concurrent surgery
- Allergy to adhesive tape
- Short Blessed Test score >20
- Clinical diagnosis of dementia
- Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Johns Hopkins University
Baltimore, Maryland, 21287
About this study
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.
- Conditions
- Hip Fractures, Hip Arthropathy, Surgery, Delirium
- Being tested
- Blood pressure management according to cerebral autoregulation, Blood pressure management according to usual care
- Medical subject headings
- Hip Fractures, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure management according to cerebral autoregulationOther
Intraoperative blood pressure will be targeted based on limits of cerebral autoregulation.
Blood pressure management according to usual careOther
Intraoperative blood pressure will be targeted based on usual care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood pressure management according to 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. Receives: Other: Blood pressure management according to usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative, up to 5 hours
Estimated Blood Loss
Blood loss during surgery (mL).
Measured: 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.
Measured: 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.
Measured: In the hospital after surgery, up to 2 weeks
Secondary outcomes (7)
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.
Measured: In the hospital during the first 3 days after surgery
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 60, 180, and 365 Days after Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start9 Jan 2023
- Primary completion28 Jun 2024
- Study completion30 Jul 2025
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 Hip FracturesStudies 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Charles Brown, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308290
- Sponsor's protocol ID
- IRB00137091
- Other IDs
- K76AG057020
- Status last verified
- Aug 2025
- First submitted
- 24 Mar 2022
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Cerebral Autoregulation During Surgery
- ClinicalTrials.gov ID
- NCT05308290
- Acronym / sponsor ID
- IRB00137091
- Conditions
- Hip Fractures, Hip Arthropathy, Surgery, Delirium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood pressure managed by cerebral autoregulation | Experimental | Other: Blood pressure management according to cerebral autoregulationIn 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 | Other: Blood pressure management according to usual careIn this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- planned hip or knee surgery (either for fracture or elective) or lung surgery
- age ≥60
- ambulatory at baseline
- expected duration of surgery > 90 minutes
Key exclusion criteria (5 listed)
- Planned concurrent surgery
- Allergy to adhesive tape
- Short Blessed Test score >20
- Clinical diagnosis of dementia
- Opinion of either the anesthesiologist or surgeon that the patient is not appropriate.
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 |
|---|---|---|
| Blood pressure management according to cerebral autoregulationIntraoperative blood pressure will be targeted based on limits of cerebral autoregulation. | Other | Blood pressure managed by cerebral autoregulation |
| Blood pressure management according to usual careIntraoperative blood pressure will be targeted based on usual care. | Other | Standard of care blood pressure management |
Primary outcome
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation
Time frame: Intraoperative, up to 5 hours
Extent (mmHg * hours) of mean arterial pressure outside limits of cerebral autoregulation after establishment of target mean arterial pressure.
Estimated Blood Loss
Time frame: Intraoperative, up to 5 hours
Blood loss during surgery (mL).
Number of Participants With New Myocardial Infarction After Surgery
Time frame: In the hospital after surgery, up to 2 weeks
Clinically diagnosed new myocardial infarction after surgery as a measure of incidence.
Number of Participants With New Stroke After Surgery
Time frame: In the hospital after surgery, up to 2 weeks
Clinically diagnosed new stroke after surgery as a measure of incidence.
7 secondary outcomes
Number of Participants That Develop Delirium After Surgery
Time frame: In the hospital during the first 3 days after surgery
Change in General Cognitive Function as Assessed by the Short Blessed Test
Time frame: Approximately 60, 180, and 365 Days after Surgery
Change in Executive Cognitive Function as Assessed by the Oral Trail Making Test
Time frame: Approximately 60, 180, and 365 Days after Surgery
Dementia Screening as Assessed by the AD8 Test
Time frame: 365 Days after Surgery
Change in General Overall Health and Disability as Assessed by the WHO Disability Assessment Schedule 2.0
Time frame: Approximately 60, 180, and 365 Days after Surgery
Change in General Function as Assessed by the Instrumental Activities of Daily Living Questionnaire
Time frame: Approximately 60, 180, and 365 Days after Surgery
Change in Ability to Ambulate Without Human Assistance
Time frame: Approximately 60, 180, and 365 Days after Surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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 Blood pressure management according to cerebral autoregulation in people with Hip Fractures and Hip Arthropathy, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 2 Sep 2025. 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 16 Jul 2025). 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?
Mean Arterial Pressure Outside Limits of Cerebral Autoregulation (time frame: Intraoperative, up to 5 hours). The study lists 4 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 2 Sep 2025.