RECRUITING

The GUARDIAN Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-07-25

Study Completion:2027-04-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04884802

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. At least 45 years old; 2. Scheduled for major noncardiac surgery expected to last at least 2 hours; 3. Having general anesthesia, neuraxial anesthesia, or the combination; 4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable); 5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life); 6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter; 7. Cared for by clinicians willing to follow the GUARDIAN protocol; 8. Subject to at least one of the following risk factors: 1. Age \>65 years; 2. History of peripheral arterial disease; 3. History of coronary artery disease; 4. History of stroke or transient ischemic attack; 5. Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months; 6. Diabetes requiring medication; 7. Current smoking or 15 pack-year history of smoking tobacco; 8. Scheduled for major vascular surgery; 9. Body mass index ≥35 kg/m2; 10. 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; 11. B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.	1. Are scheduled for carotid artery surgery; 2. Are scheduled for intracranial surgery; 3. Are scheduled for partial or complete nephrectomy; 4. Are scheduled for pheochromocytoma surgery; 5. Are scheduled for liver or kidney transplantation; 6. Require preoperative intravenous vasoactive medications; 7. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension; 8. Require beach-chair positioning; 9. Have a documented history of dementia; 10. Have language, vision, or hearing impairments that may compromise cognitive assessments; 11. Have contraindications to norepinephrine or phenylephrine per clinician judgement; 12. Have previously participated in the GUARDIAN trial.

Inclusion Criteria

Exclusion Criteria

1. At least 45 years old;
2. Scheduled for major noncardiac surgery expected to last at least 2 hours;
3. Having general anesthesia, neuraxial anesthesia, or the combination;
4. Expected to require at least overnight hospitalization (planned ICU admission is acceptable);
5. Are designated ASA physical status 2-4 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life);
6. Expected to have direct intraoperative blood pressure monitoring with an arterial catheter;
7. Cared for by clinicians willing to follow the GUARDIAN protocol;
8. Subject to at least one of the following risk factors:
1. Age \>65 years;
2. History of peripheral arterial disease;
3. History of coronary artery disease;
4. History of stroke or transient ischemic attack;
5. Serum creatinine \>175 μmol/L (\>2.0 mg/dl) within 6 months;
6. Diabetes requiring medication;
7. Current smoking or 15 pack-year history of smoking tobacco;
8. Scheduled for major vascular surgery;
9. Body mass index ≥35 kg/m2;
10. 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;
11. B-type natriuretic protein (BNP) \>80 ng/L or N-terminal B-type natriuretic protein (NTProBNP) \>200 ng/L within six months.

1. Are scheduled for carotid artery surgery;
2. Are scheduled for intracranial surgery;
3. Are scheduled for partial or complete nephrectomy;
4. Are scheduled for pheochromocytoma surgery;
5. Are scheduled for liver or kidney transplantation;
6. Require preoperative intravenous vasoactive medications;
7. Have a condition that precludes routine or tight blood pressure management such as surgeon request for relative hypotension;
8. Require beach-chair positioning;
9. Have a documented history of dementia;
10. Have language, vision, or hearing impairments that may compromise cognitive assessments;
11. Have contraindications to norepinephrine or phenylephrine per clinician judgement;
12. Have previously participated in the GUARDIAN trial.

Contacts and Locations

Study Contact

Valerie L. Anderson, BS

CONTACT

(713) 500-4383

Valerie.L.Anderson@uth.tmc.edu

Daniel Sessler, MD

CONTACT

(713) 500-3062

Daniel.Sessler@uth.tmc.edu

Principal Investigator

Daniel I Sessler, MD

PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Study Locations (Sites)

University of Nebraska Medical Center

Omaha, Nebraska, 68198

United States

Wake Forest University

Wake Forest, North Carolina, 27106

United States

MetroHealth Medical Center

Cleveland, Ohio, 44109

United States

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, 44111

United States

Cleveland Clinic Main Campus

Cleveland, Ohio, 44195

United States

The University of Texas Health Science Center at Houston

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

Daniel I Sessler, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-25

Study Completion Date2027-04-25

Study Record Updates

Study Start Date2021-07-25

Study Completion Date2027-04-25

Terms related to this study

Additional Relevant MeSH Terms

Blood Pressure