The GUARDIAN Pilot Trial

NCT04789733 | Active Not Recruiting

• 1 other identifier: The GUARDIAN pilot trial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management and prompt resumption of chronic antihypertensive medications (routine pressure management).

Conditions

General Surgery

Keywords

Blood pressure; major adverse cardiac events; Delirium; Acute kidney injury

Outcome Measures

Primary Outcomes (2)

• Intraoperative blood pressure management

  The fraction of time when intraoperative MAP is \<65 mmHg and ≥85 mmHg during surgery.

  Intraoperative

• Postoperative blood pressure management

  Time to restarting routine antihypertensive medications.

  First 3 postoperative days

Secondary Outcomes (2)

• Intraoperative pressure

  Intraoperative

• Postoperative pressure

  Initial 3 postoperative days

Other Outcomes (2)

• Perfusion-related complications

  30 days

• Delirium

  Initial 4 postoperative days

Study Arms (2)

Tight pressure management

EXPERIMENTAL

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. Resumption of chronic anti-hypertensive medications will be delayed until the third postoperative day unless deemed necessary to treat hypertension or for some other clear indication. The target for postoperative systolic arterial pressures ≥110 mmHg during the initial three postoperative days.

Other: Tight pressure management

Routine pressure management

OTHER

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. As usual, chronic anti-hypertensive medications will be restarted shortly after surgery unless contraindicated by hypotension.

Other: Routine pressure management

Interventions

Tight pressure management OTHER

Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)

Tight pressure management

Routine pressure management OTHER

Routine intraoperative blood pressure management and immediate restart of antihypertensive medications.

Routine pressure management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

China Japan Union Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (1)

• Li K, Hu Z, Li W, Shah K, Sessler D. Tight perioperative blood pressure management to reduce complications: a randomised feasibility trial. BMJ Open. 2023 Nov 17;13(11):e071328. doi: 10.1136/bmjopen-2022-071328.

  PMID: 37977865 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Delirium; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and assessors blinded to intraoperative management, postoperative antihypertensive management, and blood pressures.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel group randomized trial.

Study Record Dates

• First Submitted: January 14, 2021
• First Posted: March 10, 2021
• Study Start: April 27, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

CN (1)