Targeted Blood Pressure Management for Surgery

Overseen By Mirinda Anderson White

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Planned concurrent surgery, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for managing blood pressure during surgery. One group will have their blood pressure managed based on cerebral autoregulation, keeping it within the brain's safe range, while the other group will follow standard care practices. The researchers aim to determine if this targeted approach is feasible, safe, and potentially more effective. Individuals planning to undergo hip, knee, or lung surgery, who are 60 or older and can walk independently, might be suitable candidates for this study. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this blood pressure management protocol is safe for surgery?

Research suggests that managing blood pressure based on the brain's natural ability to regulate blood flow during surgery could be safe. This natural ability, called cerebral autoregulation, helps maintain steady blood flow. Studies have shown that when blood pressure stays within the brain's preferred range, patients may experience better outcomes. This approach aims to prevent issues like too little blood flow (ischemia) or too much blood flow (hyperaemia), which can lead to complications after surgery.

In past studies, patients whose blood pressure was managed outside their personal limits often had worse outcomes. This indicates that setting personalized blood pressure targets could be safer. While more research is needed to fully understand the safety, early findings suggest that this approach is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring a new way to manage blood pressure during surgery by focusing on cerebral autoregulation. Unlike standard care, which generally follows usual guidelines for blood pressure management, this method uses real-time monitoring to keep blood pressure within specific limits that the brain can handle. This personalized approach could lead to better outcomes for patients, as it aims to optimize blood flow to the brain during surgery, potentially reducing complications.

What evidence suggests that this trial's blood pressure management methods could be effective during surgery?

This trial will compare two approaches to blood pressure management during surgery. One arm will manage blood pressure according to cerebral autoregulation, which research has shown to be helpful. One study found a 45% reduction in confusion (delirium) in patients managed this way compared to the usual method. Another study suggested that maintaining blood pressure within these personalized limits can reduce the risk of sudden kidney problems (acute kidney injury). The other arm will follow standard care guidelines for blood pressure management. Personalized blood pressure management during surgery appears promising for better surgical outcomes and faster patient recovery. ^{5 6 7 8 9}

Who Is on the Research Team?

Charles Brown, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for people aged 60 or older who are having hip, knee, or lung surgery expected to last over 90 minutes and were able to walk before surgery. It's not for those with dementia, a high Short Blessed Test score (over 20), allergies to adhesive tape, or if the doctor thinks they're not suitable.

Inclusion Criteria

My surgery is expected to last longer than 90 minutes.

I am scheduled for hip, knee, or lung surgery.

I can walk by myself without help.

Exclusion Criteria

I am scheduled for another surgery at the same time.

My Short Blessed Test score is over 20.

Opinion of either the anesthesiologist or surgeon that the patient is not appropriate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intraoperative Monitoring

Cerebral autoregulation monitoring and blood pressure management during surgery

Up to 5 hours

1 visit (in-person, during surgery)

Postoperative Follow-up

Participants are monitored for new stroke, myocardial infarction, and delirium after surgery

1 week

In-hospital monitoring

Long-term Follow-up

Assessment of general function, cognitive function, and overall health at multiple time points after surgery

365 days

What Are the Treatments Tested in This Trial?

Interventions

• Blood pressure management according to cerebral autoregulation
• Blood pressure management according to usual care

Trial Overview The study is testing two ways of managing blood pressure during surgery: one adjusts it based on brain blood flow needs ('cerebral autoregulation'), and the other follows standard care practices. The goal is to see which method is safer and more effective.

How Is the Trial Designed?

Group I: Blood pressure managed by cerebral autoregulation Experimental Treatment 1 Intervention

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.

Group II: Standard of care blood pressure management Active Control 1 Intervention

In this arm cerebral autoregulation monitoring will be used for observation. The anesthesia provider will use usual care guidelines for blood pressure management.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

An automated closed-loop vasopressor administration device successfully maintained mean arterial pressure (MAP) within 5 mmHg of the target 80 mmHg for 98% of the intraoperative period in a swine model of induced hypotension.

This study demonstrates that norepinephrine can be accurately titrated using this automated system, suggesting a potential for improved management of intraoperative hypotension and reduced risk of postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated Titration of Vasopressor Infusion Using a Closed-loop Controller: In Vivo Feasibility Study Using a Swine Model. Joosten, A., Delaporte, A., Alexander, B., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33186735/

Personalized Blood Pressure Management During Cardiac ... Compared with the usual care there was a 45% reduction in the frequency of clinically detected delirium in the autoregulation group (8.2% vs 14.9%, risk ratio = ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3769417/

Blood Pressure Excursions Below the Cerebral Autoregulation ... These results suggest that maintaining MAP above the real-time-determined lower limit of cerebral autoregulation may be an effective strategy for reducing AKI ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878747925000042

Individualized autoregulation-guided arterial blood ... Despite an overall improvement in survival and outcomes after aSAH, limited level 1 evidence guides the management of aSAH, leading to significant controversies ...

4. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(24)00092-8/fulltext

Monitoring of cerebral blood flow autoregulation For surgical patients, personalised blood pressure management based on CBF autoregulation data holds promise as a strategy to improve patient ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00769691

Monitoring of Cerebral Blood Flow Autoregulation Using ... The goal of this research is to develop a method to individualize blood pressure during surgery to a level that is within a patient's brain blood flow ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11164832/

Cerebral autoregulation derived blood pressure targets in ... Poor postoperative outcomes may be associated with cerebral ischaemia or hyperaemia, caused by episodes of arterial blood pressure (ABP) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091224000928

Monitoring of cerebral blood flow autoregulation Observational data have linked impaired CBF autoregulation metrics to adverse outcomes in patients with traumatic brain injury, ischaemic stroke, subarachnoid ...

8. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.033633

Deviation From Personalized Blood Pressure Targets ... The burden with BP outside the autoregulatory limits was associated with poor outcome (modified Rankin Scale score 3–6) at 90 days (adjusted ...

9. jcvaonline.com jcvaonline.com/article/S1053-0770(25)00212-5/fulltext

Cerebral Autoregulation Monitoring: Time to Prioritize the ... Adverse neurological outcomes are a major concern after cardiac surgery and belong to the most dreaded perioperative adverse events.