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Targeted Blood Pressure Management for Surgery

N/A

Recruiting

Led By Charles Brown, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned hip or knee surgery (either for fracture or elective) or lung surgery

Expected duration of surgery > 90 minutes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days after surgery

Awards & highlights

Study Summary

This trial will test if it is safe and effective to target MAP within the limits of cerebral autoregulation during surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects may include variations in heart rate or blood pressure due to different management techniques. However, since this trial focuses on monitoring methods rather than new medications, fewer side effects are anticipated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My surgery is expected to last longer than 90 minutes.

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I can walk by myself without help.

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I am 60 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the hospital during the first 3 days after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the hospital during the first 3 days after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the hospital during the first 3 days after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Estimated Blood Loss

Incidence of new Myocardial Infarction after surgery

Incidence of new Stroke after surgery

+1 more

Secondary outcome measures

Change in Executive Cognitive Function as assessed by the Oral Trail Making Test

Change in General function as assessed by the Instrumental Activities of Daily Living questionnaire

Change in ability to Ambulate without human assistance

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Blood pressure managed by cerebral autoregulationExperimental Treatment1 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 managementActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,848 Total Patients Enrolled

5 Trials studying Surgery

570 Patients Enrolled for Surgery

Johns Hopkins UniversityLead Sponsor

2,266 Previous Clinical Trials

14,823,144 Total Patients Enrolled

3 Trials studying Surgery

5,000,431 Patients Enrolled for Surgery

Charles Brown, MDPrincipal InvestigatorJohns Hopkins University

7 Previous Clinical Trials

539 Total Patients Enrolled

Media Library

Blood pressure management according to cerebral autoregulation Clinical Trial Eligibility Overview. Trial Name: NCT05308290 — N/A

Surgery Research Study Groups: Blood pressure managed by cerebral autoregulation, Standard of care blood pressure management

Surgery Clinical Trial 2023: Blood pressure management according to cerebral autoregulation Highlights & Side Effects. Trial Name: NCT05308290 — N/A

Blood pressure management according to cerebral autoregulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05308290 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still seeking qualified participants?

"The clinicaltrials.gov website indicates that this trial is no longer recruiting, as the most recent update was on November 15th 2022. Despite this information, there are still 488 other studies actively looking for participants at present."

Answered by AI

Are octogenarians being included in the scope of this experiment?

"This clinical trial has set the eligibility criteria to include patients between 60 and 100 years old. For younger demographics, there are 53 trials available for under 18s and 450 for those over 65."

Answered by AI

Could I be a viable candidate for this research endeavor?

"This research project is in search of 77 individuals aged 60-100 who present with delirium. To be eligible, patients must have upcoming hip or knee surgery (for either fracture or elective purposes) or lung surgery and they need to be ambulatory until the time of the procedure which should last longer than 90 minutes."

Answered by AI

What is the desired outcome of this medical experiment?

"The principle objective of this study, measured over the period of intraoperative and up to 5 hours after surgery is to assess incidences of myocardial infarction. Secondary objectives involve gauging general functioning through an Instrumental Activities of Daily Living questionnaire (scores range from 0-8), determining how many participants develop delirium via 3D-CAM or CAM-ICU, as well as dementia screening with AD8 test scores that vary from 0-8."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing Cerebral Autoregulation During Surgery

2023. "Optimizing Cerebral Autoregulation During Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05308290.