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Blood Pressure Management During Surgery for High Blood Pressure

N/A
Recruiting
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expected to require at least overnight hospitalization
Scheduled for major noncardiac surgery expected to last at least 2 hours
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial compares two treatments to maintain blood pressure during surgery: tight or routine management.

Who is the study for?
The GUARDIAN Trial is for adults over 45 with high blood pressure who are taking medication for it and scheduled for major noncardiac surgery lasting at least 2 hours. They must be hospitalized overnight, have a certain level of systemic disease, direct blood pressure monitoring during surgery, and one additional risk factor like heart disease or diabetes. Exclusions include those needing organ transplants or specific surgeries, contraindications to the study drugs, or cognitive impairments.Check my eligibility
What is being tested?
This trial tests two ways to manage blood pressure during major surgery: 'tight' management aims to keep intraoperative mean arterial pressure (MAP) ≥85 mmHg using norepinephrine or phenylephrine infusions; 'routine' management follows standard care without this strict MAP target.See study design
What are the potential side effects?
Potential side effects from tight pressure management may include reactions related to norepinephrine or phenylephrine such as irregular heartbeat, headaches, nervousness, and possibly skin necrosis if the drug extravasates.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I expect to stay in the hospital overnight or longer.
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I am scheduled for a major surgery that is not heart-related and will last at least 2 hours.
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I have a serious health condition that affects my daily life.
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I am 45 years old or older.
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I am on long-term medication for high blood pressure.
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I will undergo surgery with general or spinal anesthesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of major perfusion-related complications
Secondary outcome measures
Cognition
Major adverse cardiac events
Postoperative delirium
Other outcome measures
Atrial Fibrillation
Hospital readmission
ICU admission

Trial Design

2Treatment groups
Experimental Treatment
Group I: Tight pressure managementExperimental Treatment1 Intervention
In patients assigned to tight blood pressure control, angiotensin converting enzyme inhibitors and angiotensin receptor blockers will not be given the morning of surgery. Other chronic antihypertensives will only be given as necessary to treat hypertension. Norepinephrine or phenylephrine infusion will be infused at a rate sufficient to maintain intraoperative MAP ≥ 85 mmHg.
Group II: Routine pressure managementExperimental Treatment1 Intervention
ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine.

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,030 Previous Clinical Trials
1,359,304 Total Patients Enrolled
Daniel I Sessler, MDStudy ChairThe Cleveland Clinic
33 Previous Clinical Trials
91,034 Total Patients Enrolled

Media Library

Routine pressure management Clinical Trial Eligibility Overview. Trial Name: NCT04884802 — N/A
High Blood Pressure Research Study Groups: Routine pressure management, Tight pressure management
High Blood Pressure Clinical Trial 2023: Routine pressure management Highlights & Side Effects. Trial Name: NCT04884802 — N/A
Routine pressure management 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884802 — N/A

Frequently Asked Questions

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

How many sites are overseeing this clinical experiment?

"This trial is available across 16 medical centres, including those in Omaha, Wake Forest and Cleveland. To reduce your travel needs when participating, it is suggested to select the clinic that’s closest to you."

Answered by AI

How many individuals are taking part in this clinical examination?

"Affirmative. According to the details on clinicaltrials.gov, this trial commenced recruitment on July 25th 2021 and is still open for applications as of August 22nd 2023. The study requires 6254 participants from a total of 16 sites."

Answered by AI

Does this research endeavor still require experimental participants?

"According to clinicaltrials.gov, the trial is open for recruitment and was initially posted on July 25th 2021 before being revised lastly on August 22nd 2023."

Answered by AI

Who else is applying?

What site did they apply to?
University of Nebraska Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
The GUARDIAN Trial
2021. "The GUARDIAN Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884802.
~1220 spots leftby Dec 2024
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