Hemodynamic Management Following Acute Traumatic Spinal Cord Injury: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic spinal cord injury
排除标准
- •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
结局指标
主要结局
Performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score
时间窗: 6 weeks following injury
There are 3 subscales on the SCIM III: self-care (4 items, score ranging from 0-20), respiration and sphincter management (4 items, score ranging from 0-40), and mobility (9 items, score ranging from 0-40). Total score ranges from 0 to 100, with a higher score indicating a better outcome.
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
时间窗: 6 weeks following injury
Upper and lower extremities will be assessed, and motor strength at each spinal cord level will be scored from 0 to 5 (0 indicates total paralysis and 5 indicates active movement against full resistance), with a maximum score of 25 for each extremity, totaling 100 for all four extremities. Total score ranges from 0 to 100, with a higher score indicating a better outcome.
次要结局
- Duration of time (hours) receiving goal caloric requirements by enteric nutrition(first 5 days of hospitalization)
- 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(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(6 months following injury, 12 months following injury)
- Number of ICU-free days(30 days from baseline)
- Number of participants developing acute kidney injury using the Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease (RIFLE) criteria(Baseline to hospital discharge or 30 days, whichever comes first)
- Change in performance in activities of daily living and mobility as assessed by the Spinal Cord Independence Measure (SCIM) III score(6 months following injury, 12 months following injury)
- Number of deaths(Baseline to hospital discharge or 30 days, whichever comes first)
- Number of participants developing a central line-associated blood stream infection(Baseline to hospital discharge or 30 days, whichever comes first)
- Number of participants developing a pneumothorax from central venous catheter insertion(Baseline to hospital discharge or 30 days, whichever comes first)
- Number of participants developing pneumonia(Baseline to hospital discharge or 30 days, whichever comes first)
研究者
David E. Meyer, MD, MS, FACS
Associate Professor
The University of Texas Health Science Center, Houston