The GUARDIAN Trial - Vasopressor Sub-Study

Официальное название

Tight Perioperative Blood Pressure Management to Reduce Serious Cardiovascular, Renal, and Cognitive Complications: The GUARDIAN Trial (Vasopressor Sub-study Comparing Phenylephrine and Norepinephrine)

Обзор

This is a sub-study of the overall GUARDIAN trial (NCT04884802) in which some GUARDIAN trial participants will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Подробное описание

Participants in the underlying GUARDIAN trial (NCT04884802) will be randomized to: 1) norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg (tight pressure management); or, 2) routine intraoperative blood pressure management (routine pressure management). Participants in this sub-study will be additionally randomized to norepinephrine or phenylephrine infusion to maintain the designated target intraoperative mean arterial pressure.

Вмешательства

• Процедура Routine Blood Pressure Management
  Routine blood pressure control.
• Процедура Tight Blood Pressure Management
  Tight blood pressure control.
• Препарат Phenylephrine
  Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
• Препарат Norepinephrine
  Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.

Первичные конечные точки

• Number of Participants with a Composite of Major Perfusion-Related Complications [Срок оценки: During the initial 30 days after major non-cardiac surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 or kidney 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 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 the GUARDIAN trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Китай · 5 центров

• Beijing Shijitan Hospital, Capital Medical University — Пекин
• Peking Union Medical College Hospital — Пекин
• Shanghai Ninth People's Hospital — Шанхай
• Shanghai Chest Hospital — Шанхай
• West China Hospital — Sichuan

США · 4 центра

• University of Nebraska Medical Center — Omaha
• MetroHealth Medical Center — Cleveland
• Cleveland Clinic Fairview Hospital — Cleveland
• Cleveland Clinic Main Campus — Cleveland

Греция · 1 центр

• University of Thessaly — Larissa

Япония · 1 центр

• National Defense College — Tokyo

Идентификаторы

NCT: NCT04934748 · HSC-MS-24-1026 (vasopressor)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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