Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

An international randomized trial to test the primary hypothesis that perioperative tight blood pressure management reduces a composite of major perfusion-related complications (myocardial injury, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, deep or organ-space infection, sepsis, and death) in the 30 days after major non-cardiac surgery. The treatments will be: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• At least 45 years old;

• Scheduled for major noncardiac surgery expected to last at least 2 hours;

• Having general anesthesia, neuraxial anesthesia, or the combination;

• Expected to require at least overnight hospitalization (planned ICU admission is acceptable);

• Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);

• Expected to have direct intraoperative 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:

‣ Age \>65 years;

⁃ History of peripheral arterial disease;

⁃ History of coronary artery disease;

⁃ History of stroke or transient ischemic attack;

⁃ Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months;

⁃ 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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay), 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays - all within 6 months;

‣ B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.

Locations
United States
North Carolina
Wake Forest University
COMPLETED
Wake Forest
Nebraska
University of Nebraska Medical Center
COMPLETED
Omaha
Ohio
Cleveland Clinic Fairview Hospital
COMPLETED
Cleveland
Cleveland Clinic Main Campus
COMPLETED
Cleveland
MetroHealth Medical Center
RECRUITING
Cleveland
Texas
The University of Texas Health Science Center at Houston
RECRUITING
Houston
Other Locations
China
Beijing Shijitan Hospital, Capital Medical University
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
West China University Hospital
RECRUITING
Chengdu
Prince of Wales Hospital, Chinese University of Hong Kong, Shatin
RECRUITING
Hong Kong
Renji Hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Shanghai Chest Hospital
RECRUITING
Shanghai
Shanghai Ninth People's Hospital
RECRUITING
Shanghai
The Affiliated Lianyungang Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Greece
University of Thessaly
COMPLETED
Larissa
Italy
IRCCS Regina Elena National Cancer Institute
RECRUITING
Rome
Japan
National Defense Medical College
RECRUITING
Tokyo
Turkey
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
RECRUITING
Bakırköy
Konya City Hospital
RECRUITING
Konya
Contact Information
Primary
Valerie L. Anderson, BS
Valerie.L.Anderson@uth.tmc.edu
(713) 500-4383
Backup
Daniel Sessler, MD
Daniel.Sessler@uth.tmc.edu
(713) 500-3062
Time Frame
Start Date: 2021-07-25
Estimated Completion Date: 2027-04-25
Participants
Target number of participants: 6254
Treatments
Experimental: Tight blood pressure management
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.
Other: Routine blood pressure management
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.
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov

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