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

27 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

Is targeted blood pressure management for surgery safe for humans?

Research suggests that managing blood pressure during surgery can be safe and may reduce adverse events, especially when personalized to the patient's needs. However, it is important to consider individual conditions, such as chronic hypertension or brain issues, to ensure safety. ^{1 2 3 4 5}

How is the targeted blood pressure management treatment for surgery different from other treatments?

This treatment is unique because it focuses on personalizing blood pressure management during surgery by targeting an individual's optimal blood pressure, which is determined through monitoring cerebral blood flow autoregulation. This approach aims to ensure adequate organ perfusion and minimize complications, unlike standard treatments that may not consider individual variations. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment for blood pressure management according to cerebral autoregulation?

Research suggests that managing blood pressure by considering cerebral autoregulation (the brain's ability to maintain stable blood flow) is important, especially in patients with conditions like stroke or intracerebral hemorrhage. This approach can help prevent further brain damage by ensuring adequate blood flow without causing additional pressure on the brain. ^{1 6 8 9 10}

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.

I have been diagnosed with dementia.

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. United States pubmed.ncbi.nlm.nih.gov

Cerebral hemorrhage and edema following brain biopsy in rats: significance of mean arterial blood pressure. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

Acute blood pressure increase during the perioperative period. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of antihypertensive agents on cerebral blood flow and flow velocity in acute ischaemic stroke: systematic review of controlled studies. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Secondary decline of cerebral autoregulation is associated with worse outcome after intracerebral hemorrhage. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Management of hypertension in patients with acute stroke. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Automated Titration of Vasopressor Infusion Using a Closed-loop Controller: In Vivo Feasibility Study Using a Swine Model. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Tight Control of Systolic Blood Pressure in Spontaneous Intraparenchymal Brain Hemorrhage. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Perioperative Antihypertensive Treatment in Patients With Spontaneous Intracerebral Hemorrhage. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Personalization of arterial pressure in the perioperative period. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Perioperative optimal blood pressure as determined by ultrasound tagged near infrared spectroscopy and its association with postoperative acute kidney injury in cardiac surgery patients. [2018]