Hemodynamic Management Following Acute Traumatic Spinal Cord Injury

Официальное название

Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial

Обзор

The purpose of this study is to assess the effect of various hemodynamic management strategies on functional neurologic outcomes and non-neurologic adverse events in the first 5 days following acute spinal cord injury (SCI). The hemodynamic management strategies assessed include targeting a mean arterial blood pressure (MAP) goal of 85-90 mmHg, targeting a spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg, or targeting normal hemodynamics, which is a MAP goal of ≥65 mmHg.

Вмешательства

• Другое Mean arterial blood pressure (MAP) goal of ≥65 mmHg
  The treatment team will maintain MAP ≥65 mmHg for the first five days following injury.
• Другое Mean arterial blood pressure (MAP) goal of 85-90 mmHg
  The treatment team will maintain MAP 85-90 mmHg for the first five days following injury.
• Другое Spinal cord perfusion pressure (SCPP) goal of ≥65 mmHg
  The treatment team will maintain SCPP ≥65 mmHg for the first five days following injury.

Первичные конечные точки

• The severity of a spinal cord injury (SCI) as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score [Срок оценки: 6 weeks following injury]
• Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score [Срок оценки: 6 weeks following injury]

Вторичные конечные точки (10)

• Change in motor function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) motor score [Срок оценки: 6 months following injury, 12 months following injury]
• Change in sensory function as assessed by the American Spinal Injury Association (ASIA) International Standards for Neurological Classification of Spinal Cord Injury (ISNCSC) sensory score [Срок оценки: 6 months following injury, 12 months following injury]
• Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score [Срок оценки: 6 months following injury, 12 months following injury]
• Number of ICU-free days [Срок оценки: 30 days from baseline]
• Duration of time (hours) receiving goal caloric requirements by enteric nutrition [Срок оценки: first 5 days of hospitalization]
• Number of participants developing a central line-associated blood stream infection [Срок оценки: Baseline to hospital discharge or 30 days, whichever comes first]
• Number of participants developing a pneumothorax from central venous catheter insertion [Срок оценки: Baseline to hospital discharge or 30 days, whichever comes first]
• Number of participants developing pneumonia [Срок оценки: Baseline to hospital discharge or 30 days, whichever comes first]
• Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria [Срок оценки: Baseline to hospital discharge or 30 days, whichever comes first]
• Number of deaths [Срок оценки: Baseline to hospital discharge or 30 days, whichever comes first]

Критерии участия

Критерии включения

• Traumatic spinal cord injury

Критерии исключения

• Patients with an injury from a trauma that penetrates the spinal cord (i.e., gunshot or knife wound resulting in cord transection)
• Preexisting neurologic or spinal cord injury
• Severe traumatic brain injury as measured by a best resuscitated Glasgow Coma Scale (GCS) score of <8 at 24 hours following injury
• Presence of traumatic injuries that preclude spine surgery within 24 hours of presentation
• Concomitant injury/illness requiring targeted blood pressure management (e.g., injury to the aorta, aortic dissection, hemorrhagic stroke)
• Preexisting history of neuromotor disorders (i.e., cerebral palsy, Parkinson disease, etc.)
• Not expected to survive >24h
• Cord transection identified by radiologist and agreed upon by the spine surgery team
• Injury below spinal cord level L1
• Prisoners
• Pregnant women

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06451133 · HSC-MS-24-0405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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