Can keeping blood pressure higher during surgery prevent organ damage?
NCT ID NCT04789733
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tests whether keeping blood pressure higher than usual during and after major surgery can reduce serious complications like heart attack, kidney injury, and confusion. About 80 adults aged 45 and older who take blood pressure medication and are having long surgeries will be randomly assigned to either tight or routine blood pressure management. The goal is to see if this approach is feasible and safe before a larger trial.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- norepinephrine or phenylephrine (medicines to raise blood pressure)
- What this could lead to
- If it works, this could point toward a standard way to manage blood pressure during surgery to lower the risk of serious complications.
- What could go wrong
- This is a very small pilot study with only 80 people, so results may not apply widely. The tight control approach could also cause side effects like too-high blood pressure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Apr 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥45 years old * Scheduled for major noncardiac surgery expected to last at least 2 hours; * Having general endotracheal, neuraxial anesthesia, or the combination; * Expected to require at least overnight hospitalization; * Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life); * Chronically taking at least one anti-hypertensive medication; * Expected to have direct blood pressure monitoring with an arterial catheter; * Cared for by clinicians willing to follow the GUARDIAN protocol; * Subject to at least one of the following risk factors: * History of peripheral arterial surgery; * History of coronary artery disease; * History of stroke or transient ischemic attack; * Serum creatinine \>175 µmol/L (\>2.0 mg/dl); * Diabetes requiring medication; * Current smoking or 15 pack-year history of smoking tobacco; * Scheduled for major vascular surgery; * Body mass index ≥35 kg/m2; * Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent; * B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) \>100 ng/L Exclusion Criteria: * Are scheduled for carotid artery surgery; * Are scheduled for intracranial surgery; * Are scheduled for partial or complete nephrectomy; * Are scheduled for pheochromocytoma surgery; * Are scheduled for liver transplantation; * Require preoperative intravenous vasoactive medications; * Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; * Require beach-chair positioning; * Have end-stage renal disease requiring dialysis or estimated glomerular filtration rate (eGFR) \<30 ml/min; * Have a documented history of dementia; * Have language, vision, or hearing impairments that may compromise cognitive assessments; * Have contraindications to norepinephrine or phenylephrine per clinician judgement; * Have previously participated in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
China Japan Union Hospital of Jilin University
Changchun, Jilin, China
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Other studies related to the condition(s) this trial covers.
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